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Tags:MifeprexFDA, pregnancy, infections, adverse, Clostridium, Ectopic, Marketing, mifepristone, severe, deaths, Termination, EVENTS, Cases, reports, Women, table, summary, September, united


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PID D050121
Mifepristone Postmarketing Adverse Events Summary 02/15/2005
The following information from United States post-marketing reports (i.e., not from
clinical trial) received FDA adverse events that occurred among patients who had
taken mifepristone for medical termination
pregnancy. Because FDA has eliminated
duplicate reports that have identified, and some cases, reclassified the adverse
event terms for individual cases after reviewing the narrative details, the numbers
provided here may differ from the numbers ofthe reports that may obtained through
Freedom Information Act requests. These events cannot with certainty causally
attributed mifepristone because information gaps about patient health status, clinical
management the patient, concurrent drug use and other possible medical surgical
treatments. The estimated number women who have used mifepristone the
this time over 300,000 women.
Post-Marketing Adverse Events Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
approval date (September 2000)
Cases with any adverse event
Died
02/15/2005
752
Hospitalized, excluding deaths
160
*Ectopic pregnancies
*Experienced blood loss requiring
transfi
usions3
*Infections
these women are included the hospitalized category. Deaths were associated with ruptured ectopic pregnancy one case and with septic The majority
shock the other two. There were three additional deaths foreign women (one
foreign clinical trial associated with septic shock, and two post marketing experience
associated with ruptured gastric ulcer one and with uterine hemorrhage the other)
who used mifepristone for termination
pregnancy. Administration mifepristone and misoprostol contraindicated patients with
confirmed suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for
average of9-16 days, and may last for days. This category includes endometritis (involviiig the lining the womb), pelvic
inflammatory disease (involving the nearby reproductive organs such the fallopian
tubes ovaries), and pelvic infections with sepsis serious infection that has spread
beyond the reproductive organs). Not included
are women with reported sexually
transmitted infections such Chlamydia infections and gonorrhea, and women with
toxic shock syndrome not associated with pelvic infection.
PID D050309
Mifepristone Postmarketing Adverse Events Summary 05/09/2005
The following information from United States post-marketing reports (i.e., not from
clinical trial) received FDA adverse events that occurred among patients who had
pregnancy. Because FDA has eliminated
taken mifepristone for medical termination
duplicate reports that have identified, and some cases, reclassified the adverse
event terms for individual cases after reviewing the narrative details, the numbers
provided here may differ from the numbers fthe reports that may obtained through
Freedom Information Act requests. These events cannot with certainty causally
attributed mifepristone because information gaps about patient health status, clinical
management the patient, concurrent drug use and other possible medical surgical
treatments. The estimated number women who have used mifepristone the
through the end April 2005 over 436,500 women.
Post-Marketing Adverse Events Women Who Used Mifepristone for
Termination Pre2nancy
Cut off date cumulative reports since
approval date (September 2000)
Cases with any adverse event
Died
Hospitalized, excluding deaths
*Ectopic pregnancies
*Experienced blood loss requiring
05/09/2005
805
177
transfusions
*Infections
these women are included the hospitalized category. Deaths were associated with ruptured ectopic pregnancy one case and with septic The majority
shock the other two. The preliminary cause death the fourth case was
cardiopulmonary arrest, possibly the setting sepsis. There were three additional
deaths foreign women (one foreign clinical trial associated with septic shock, and
two post marketing experience associated with ruptured gastric ulcer one and with
uterine hemorrhage the other) who used mifepristone for termination pregnancy. Administration mifepristone and misoprostol contraindicated patients with
confirmed suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for
average days, and may last for days. This category includes endometritis (involving the lining the womb), pelvic
inflammatory disease (involving the nearby reproductive organs such the fallopian
tubes ovaries), and pelvic infections with sepsis serious infection that has spread
beyond the reproductive organs). Not included are women with reported sexually
transmitted infections such Chlamydia infections and gonorrhea, and women with
toxic shock syndrome not associated with pelvic infection.
pin n050461
Mifepristone Postmarketing Adverse Events Summary 08/05/2005
The following information from United States post-marketing reports (i.e., not from
clinical trial) received FDA adverse events that occurred among patients who had
taken mifepristone for medical termination
pregnancy. Because FDA has eliminated
duplicate reports that have identified, and some cases, reclassified the adverse
event terms for individual cases after reviewing the narative details, the numbers
provided here may differ from the numbers the reports that may obtained through
Freedom Information Act requests. These events cannot with certainty causally
attributed mifepristone because information gaps about patient health status, clinical
management the patient, concurrent drug use and other possible medical surgical
treatments. The estimated number women who have used mifepristone the
through the end June 2005 over 460,000 women.
Post-Marketing Adverse Events Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
approval date (September 2000)
Cases with any adverse event
Died
Hospitalized, excluding deaths
*Ectopic pregnancies
*Experienced blood loss requir
08/03/2005
866
200
100
transfusions
*Infections
these women are included the hospitalized category. Deaths were associated with ruptured ectopic pregnancy one case and with septic The majority
shock the other two. The preliminary cause death the fourth case was
cardiopulmonary arrest, possibly the setting sepsis. The fifth case was also possibly
related sepsis. There were three additional deaths foreign women (one foreign
with septic shock, and two post marketing experience
associated with ruptured gastric ulcer one and with uterine hemorrhage the other)
who used mifepristone for termination pregnancy. Administration mifepristone and misoprostol contraindicated patients with
clinical trial associated
confirmed suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for
average of9-16 days, and may last for days. This category includes endometritis (involving the lining the womb), pelvic
inflammatory disease (involving the nearby reproductive organs such the fallopian
tubes ovaries), and pelvic infections with sepsis serious infection that has spread
beyond the reproductive organs). Not included are women with reported sexually
transmitted infections such Chlamydia infections and gonorrhea, and women with
toxic shock syndrome not associated with pelvic infection.
PID D050652
Mifepristone Postmarketing Adverse Events Summary 11/05/2005
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination
pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the reports that may obtained through
the numbers provided here may differ from the numbers
Freedom Information Act requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and either possible medical surgical treatments. The estimated number women.
who have used mifepristone the through the end
October 2005 approximately 508,000 women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
11/05/2005
Cut offdate cumulative reports since approval date (September 2000)
905
Cases with any adverse event
Died
Hospitalized, excluding deaths
220
*Ectopic pregnancies
*Experienced blood loss requiring transfusions
*Infections
(Severe infectionss)
105
(16)
these women are included the hospitalized category. Deaths were associated with sepsis four cases (all cases tested positive for Clostridium sordelli), the
fifth death was associated with ruptured ectopic pregnancy and the sixth death was associated with
delayed onset
toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and
fibroid cultures were positive for Prevotella). There were three additional deaths foreign women who The majority
used mifepristone for termination
pregnancy. One death foreign clinical trial was associated with
septic shock (Clostridium sordelli was identified tissue samples). The other two foreign deaths were
from the post marketing experience and were associated with ruptured gastric ulcer one and with
uterine hemorrhage the other. Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus).
stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days. This category includes endometritis (involving the lining
the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, and women
with toxic shock syndrome not associated with pelvic infection. This subset medical review
infections includes cases that were determined severe based
the case details. Severe infections generally involve hospitalization for least days, intravenous
antibiotics for least hours, total antibiotic usage for least days, and other physical clinical
findings, laboratory data surgery that suggest severe infection.
PID D060125
Mifepristone Postmarketing Adverse Events Summary Through 01/31/2006
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination
pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the reports that may obtained through
the numbers provided here may differ from the numbers
Freedom Information Act requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
women
concurrent drug use and other possible medical surgical treatments. The estimated number
who have used mifepristone the through the end October 2005 approximately 508,000 women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination ofPreQ:nanc
01/31i2006
Cut off date cumulative reports since approval date (September 2000)
Cases with any adverse event
Died
Hospitalized, excluding deaths
*Ectopic pregnancies
*Experienced blood loss requiring transfusions
*Infections
(Severe infectionss)
944
234
114
(17)
these women are included the hospitalized category. Deaths were associated with sepsis four cases (all cases tested positive for Clostridium sordellii), the
associated with
fifth death was associated with ruptured ectopic pregnancy and the sixth death was
toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and
delayed onset
fibroid cultures were positive for Prevotella). There were three additional deaths foreign women who
used mifepristone for termination pregnancy. One death foreign clinical trial was associated with
septic shock (Clostridium sordelli was identified tissue samples). The other two foreign deaths were
from the post marketing experience and were associated with ruptured gastric ulcer one and with The majority
uterine hemorrhage the other. Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for .an average 9-16 days,
and may last for days. This category includes endometritis (involviiig the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection. This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve hospitalization for least days, intravenous
antibiotics for least hours, total antibiotic usage for least days, and other physical clinical
findings, laboratory data surgery that suggest severe infection.
Pil D060452
Mifepristone Postmarketing Adverse Events Summary Through 04/30/2006
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had
taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the reports that may obtained through
the numbers provided here may differ from the numbers
Freedom Information Act requests. These events cannot with certainty causally attributed
about patient health status, clinical management the patient,
mifepristone because information gaps
women
concurrent drug use and other possible medical surgical treatments. The estimated number
March 2006 approximately 575,000 women.
who have used mifepristone the through the end
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pree:nanc
Cut off date cumulative reports since approval date (September 2000)
Cases with any adverse event
Died
Hospitalized, excluding deaths
*Ectopic pregnancies
*Experienced blood loss requiring transfusions
*Infections
(Severe infections5)
04/30/2006
1,027
250
129
103
(18)
these women are included the hospitalized category. Deaths were associated with sepsis five cases cases tested positive for Clostridium sordelli, case The majority
tested positive for Clostridium perfringens). The four remaining u.s. deaths involved unique events;
there was one case each ruptured ectopic pregnancy, methadone overdose, suspected homicide, and
toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and
delayed onset
who
fibroid cultures were positive for Prevotella). There were three additional deaths foreign women
used mifepristone for termination pregnancy. One death foreign clinical trial was associated with
septic shock (Clostridium sordelli was identified tissue samples). The other two foreign deaths were
from the post marketing experience and were associated with ruptured gastric ulcer one and with
uterine hemorrhage the other. Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection. This subset infections includes cases that were determined severe based medical review This category includes endometritis (involving the lining
the case details. Severe infections generally involve hospitalization for least days, intravenous
antibiotics for least hours, total antibiotic usage for least days, and any other physical clinical
findings, laboratory data surgery that suggest severe infection.
PID D060590
Mifepristone Postmarketing Adverse Events Summary Through 07/24/2006
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination
pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some -cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the reports that may obtained through
the numbers provided here may differ from the numbers
Freedom Information Act requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end June 2006 approximately 612,000 women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination ofPree:nancv
Cut off date cumulative reports since approval date (September 2000)
07/24/2006
Cases with any adverse event
Died
Hospitalized, excluding deaths
*Ectopic pregnancies
*Experienced blood loss requiring transfusions
*Infections
(Severe infections5)
1,077
261
135
120
(21) The majority ofthese women are included the hospitalized category. Deaths were associated withsepsis five cases cases tested positive for Clostridium sordellii, case
tested positive for Clostridium perfringens). The four remaining U.S. deaths involved unique events;
ruptured ectopic pregnancy, methadone overdose, suspected homicide, and
there was one case each
delayed onset oftoxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and
fibroid cultures were positive for Prevotella). There were four additional deaths foreign women who
pregnancy. One death foreign clinical trial ~as associated with
used mifepristone for termination
septic shock (Clostridium sordelli was identified tissue samples). The other three foreign deaths were
were associated with ruptured gastric ulcer, uterine hemorrhage,
from the post marketing experience and
and multiviscera1 failure. Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days. This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection. This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for atleast 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
Pil 2006-265
Mifepristone Postmarketing Adverse Events Summary Through 09/15/2006
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the reports that may obtained through
the numbers provided here may differ from the numbers
Freedom Information Act requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end June 2006 approximately 612,000 women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination ofPreimanc
Cut off date cumulative reports since approval date (September 2000)
Cases with any adverse event
Died
Hospitalized, excluding deaths
*Ectopic pregnancies
*Experienced blood loss requiring transfusions
*Infections
(Severe infectionss)
09/15/2006
1,079
263
135
122
(22)
these women are included the hospitalized category. Deaths were associated with sepsis five cases cases tested positive for Clostridium sordelli, case The majority
tested positive for Clostridium perfringens). The four remaining U.S. deaths involved unique events;
ruptured ectopic pregnancy, methadone overdose, suspected homicide, and
there was one case each
positive for Peptostreptococcus and
toxic
shock-like
syndrome (uterine cultures were
delayed onset
fibroid cultures were positive for Prevotella). There were four additional deaths foreign women who
used mifepristone for termination pregnancy. One death foreign clinical trial was associated with
septic shock (Clostridium sordelli was identified tissue samples). The other three foreign deaths were
from the post marketing experience and were associated with ruptured gastric ulcer, uterine hemorrhage,
and multivisceral failure. Administration ofmifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days. This category includes endometritis (involving the lining ofthe womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection. This subset infections includes cases that were determined severe based medical review
hospitalization for least 2-3 days,
the case details. Severe infections generally involve death
other
least hours, total antibiotic usage for least days, and any
intravenous antibiotics for
physical clinical findings, laboratory data surgery that suggest severe infection.
PID 2006-795
Mifepristone Postmarketing Adverse Events Summary Through 10/31/2006
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the numbers provided here may differ from the numbers the reports that may obtained through
Freedom Information Act requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end June 2006 approximately 612,000 women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since approval date
10/31/2006 (September 2000)
Cases with any adverse event
1,119
Died
Hospitalized, excluding deaths
273
*Ectopic pregnancies
*Experienced blood loss requiring transfusions
140
*Infections
130
(Severe infections5)
(22) The majority these women are included the hospitalized category.
Deaths were associated with sepsis five cases cases tested positive for Clostridium sordellii, case
tested positive for Clostridium perfringens). The four remaining U.S. deaths involved unique events;
there was one case each ruptured ectopic pregnancy, methadone overdose, suspected homicide, and
delayed onset toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and
fibroid cultures were positive for Prevotella). There were four additional deaths foreign women who
used mifepristone for termination pregnancy. One death foreign clinical trial was associated with
septic shock (Clostridium sordellii was identified tissue samples). The other three foreign deaths were
from the post marketing experience and were associated with ruptured gastric ulcer, uterine hemorrhage,
and multivisceral failure
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
RCM 2007-525
Mifepristone Postmarketing Adverse Events Summary Through 1/31/2007
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the numbers provided here may differ from the numbers the reports that may obtained through
Freedom Information Act requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end June 2006 approximately 612,000 women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
10/31/07
1/31/2007
approval date (September 2000)
Cases with any adverse event
1,119
1,154
Died
Hospitalized, excluding deaths
273
292
*Ectopic pregnancies
*Experienced blood loss requiring
140
150
transfusions
*Infections
130
134
(Severe infections5)
(22)
(24) The majority these women are included the hospitalized category.
Deaths were associated with sepsis five cases cases tested positive for Clostridium sordellii, case
tested positive for Clostridium perfringens). The four remaining U.S. deaths involved unique events;
there was one case each ruptured ectopic pregnancy, methadone overdose, suspected homicide, and
delayed onset toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and
fibroid cultures were positive for Prevotella). There were four additional deaths foreign women who
used mifepristone for termination pregnancy. One death foreign clinical trial was associated with
septic shock (Clostridium sordellii was identified tissue samples). The other three foreign deaths were
from the post marketing experience and were associated with ruptured gastric ulcer, uterine hemorrhage,
and multivisceral failure
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
RCM 2007-525
Mifepristone Postmarketing Adverse Events Summary Through 1/31/2007
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the numbers provided here may differ from the numbers the reports that may obtained through
Freedom Information Act requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end May 2007 approximately 750,000 women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
1/31/2007
4/30/2007
approval date (September 2000)
Cases with any adverse event
1,154
1,199
Died
Hospitalized, excluding deaths
292
311
*Ectopic pregnancies
*Experienced blood loss requiring
150
160
transfusions
*Infections
134
138
(Severe infections5)
(24)
(26) The majority these women are included the hospitalized category.
Deaths were associated with sepsis five cases cases tested positive for Clostridium sordellii, case
tested positive for Clostridium perfringens). The four remaining U.S. deaths involved unique events;
there was one case each ruptured ectopic pregnancy, methadone overdose, suspected homicide, and
delayed onset toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and
fibroid cultures were positive for Prevotella). There were five additional deaths foreign women who
used mifepristone for termination pregnancy. One death foreign clinical trial was associated with
septic shock (Clostridium sordellii was identified tissue samples). The other four foreign deaths were
from the post marketing experience and were associated with ruptured gastric ulcer, uterine hemorrhage,
multivisceral failure and thrombotic thrombocytopenic purpura leading intracranial hemorrhage.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
RCM 2007-525
Mifepristone Postmarketing Adverse Events Summary Through 07/31/2007
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the numbers provided here may differ from the numbers the reports that may obtained through
Freedom Information Act requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end May 2007 approximately 750,000 women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
4/30/2007
7/31/07
approval date (September 2000)
Cases with any adverse event
1,199
1,243
Died
Hospitalized, excluding deaths
311
320
*Ectopic pregnancies
*Experienced blood loss requiring
160
166
transfusions
*Infections
138
148
(Severe infections5)
(26)
(27) The majority these women are included the hospitalized category.
Deaths were associated with sepsis six cases cases tested positive for Clostridium sordellii, case
tested positive for Clostridium perfringens). The four remaining U.S. deaths involved unique events;
there was one case each ruptured ectopic pregnancy, methadone overdose, suspected homicide, and
delayed onset toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and
fibroid cultures were positive for Prevotella). There were five additional deaths foreign women who
used mifepristone for termination pregnancy. One death foreign clinical trial was associated with
septic shock (Clostridium sordellii was identified tissue samples). The other four foreign deaths were
from the post marketing experience and were associated with ruptured gastric ulcer, uterine hemorrhage,
multivisceral failure and thrombotic thrombocytopenic purpura leading intracranial hemorrhage.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
RCM 2007-525
Mifepristone U.S. Postmarketing Adverse Events Summary Through 10/31/2007
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the numbers provided here may differ from the numbers the reports that may obtained through
Freedom Information Act requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end May 2007 approximately 750,000 women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
7/31/07
10/31/07
approval date (September 2000)
Cases with any adverse event
1,243
1,283
Died
Hospitalized, excluding deaths
320
331
*Ectopic pregnancies
*Experienced blood loss requiring
166
172
transfusions
*Infections
148
154
(Severe infections5)
(27)
(28) The majority these women are included the hospitalized category.
Deaths were associated with sepsis six cases cases tested positive for Clostridium sordellii, case
tested positive for Clostridium perfringens). The four remaining U.S. deaths involved unique events;
there was one case each ruptured ectopic pregnancy, methadone overdose, suspected homicide, and
delayed onset toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and
fibroid cultures were positive for Prevotella). There were five additional deaths foreign women who
used mifepristone for termination pregnancy. One death foreign clinical trial was associated with
septic shock (Clostridium sordellii was identified tissue samples). The other four foreign deaths were
from the post marketing experience and were associated with ruptured gastric ulcer, uterine hemorrhage,
multivisceral failure and thrombotic thrombocytopenic purpura leading intracranial hemorrhage.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
RCM 2007-525
Mifepristone U.S. Postmarketing Adverse Events Summary Through 1/31/2008
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the numbers provided here may differ from the numbers the reports that may obtained through
Freedom Information Act requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end January 2008 approximately 855,000 women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
10/31/07
1/31/08
approval date (September 2000)
Cases with any adverse event
1,283
1,310
Died
Hospitalized, excluding deaths
331
336
*Ectopic pregnancies
*Experienced blood loss requiring
172
172
transfusions
*Infections
154
157
(Severe infections5)
(28)
(29) The majority these women are included the hospitalized category.
Deaths were associated with sepsis six cases cases tested positive for Clostridium sordellii, case
tested positive for Clostridium perfringens). The four remaining U.S. deaths involved unique events;
there was one case each ruptured ectopic pregnancy, methadone overdose, suspected homicide, and
delayed onset toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and
fibroid cultures were positive for Prevotella). There were five additional deaths foreign women who
used mifepristone for termination pregnancy. One death foreign clinical trial was associated with
septic shock (Clostridium sordellii was identified tissue samples). The other four foreign deaths were
from the post marketing experience and were associated with ruptured gastric ulcer, uterine hemorrhage,
multivisceral failure and thrombotic thrombocytopenic purpura leading intracranial hemorrhage.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
RCM 2007-525
Mifepristone U.S. Postmarketing Adverse Events Summary through 7/31/2008
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the numbers provided here may differ from the numbers the reports that may obtained through
Freedom Information requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end September 2008 approximately 979,000
women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
4/30/08
7/31/08
approval date (September 2000)
Cases with any adverse event
1350
1398
Died
Hospitalized, excluding deaths
348
360
*Ectopic pregnancies
*Experienced blood loss requiring
179
190
transfusions
*Infections
164
168
(Severe infections5)
(29)
(30) The majority these women are included the hospitalized category.
Deaths were associated with sepsis six cases cases tested positive for Clostridium sordellii, case
tested positive for Clostridium perfringens). The four remaining U.S. deaths involved unique events;
there was one case each ruptured ectopic pregnancy, methadone overdose, suspected homicide, and
delayed onset toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and
fibroid cultures were positive for Prevotella). There were five additional deaths foreign women who
used mifepristone for termination pregnancy. One death foreign clinical trial was associated with
septic shock (Clostridium sordellii was identified tissue samples). The other four foreign deaths were
from the post marketing experience and were associated with ruptured gastric ulcer, uterine hemorrhage,
multivisceral failure and thrombotic thrombocytopenic purpura leading intracranial hemorrhage.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
RCM 2007-525
NDA 20-687
Mifepristone U.S. Postmarketing Adverse Events Summary through 10/31/2008
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the numbers provided here may differ from the numbers the reports that may obtained through
Freedom Information requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end September 2008 approximately 979,000
women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
7/31/08
10/31/08
approval date (September 2000)
Cases with any adverse event
1398
1436
Died
Hospitalized, excluding deaths
359
368
*Ectopic pregnancies
*Experienced blood loss requiring
190
198
transfusions
*Infections
168
170
(Severe infections
(30)
(30) The majority these women are included the hospitalized category.
Deaths were associated with sepsis six cases cases tested positive for Clostridium sordellii, case
tested positive for Clostridium perfringens). The four remaining U.S. deaths involved unique events;
there was one case each ruptured ectopic pregnancy, methadone overdose, suspected homicide, and
delayed onset toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and
fibroid cultures were positive for Prevotella). There were five additional deaths foreign women who
used mifepristone for termination pregnancy. One death foreign clinical trial was associated with
septic shock (Clostridium sordellii was identified tissue samples). The other four foreign deaths were
from the post marketing experience and were associated with ruptured gastric ulcer, uterine hemorrhage,
multivisceral failure and thrombotic thrombocytopenic purpura leading intracranial hemorrhage.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
Correction: The number hospitalizations was incorrectly reported 360 the pervious
update
RCM 2007-525
NDA 20-687
Mifepristone U.S. Postmarketing Adverse Events Summary through 01/31/2009
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the numbers provided here may differ from the numbers the reports that may obtained through
Freedom Information requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end September 2008 approximately 979,000
women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
10/31/08
01/31/09
approval date (September 2000)
Cases with any adverse event
1436
1483
Died
Hospitalized, excluding deaths
368
385
*Ectopic pregnancies
*Experienced blood loss requiring
198
208
transfusions
*Infections
170
174
(Severe infections
(30)
(32) The majority these women are included the hospitalized category.
Deaths were associated with sepsis six cases cases tested positive for Clostridium sordellii, case
tested positive for Clostridium perfringens). The four remaining U.S. deaths involved unique events;
there was one case each ruptured ectopic pregnancy, methadone overdose, suspected homicide, and
delayed onset toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and
fibroid cultures were positive for Prevotella). There were five additional deaths foreign women who
used mifepristone for termination pregnancy. One death foreign clinical trial was associated with
septic shock (Clostridium sordellii was identified tissue samples). The other four foreign deaths were
from the post marketing experience and were associated with ruptured gastric ulcer, uterine hemorrhage,
multivisceral failure and thrombotic thrombocytopenic purpura leading intracranial hemorrhage.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
RCM 2007-525
NDA 20-687
Mifepristone U.S. Postmarketing Adverse Events Summary through 07/31/2009
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the numbers provided here may differ from the numbers the reports that may obtained through
Freedom Information requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end May 2009 approximately 1.1 million women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
4/30/09
07/31/09
approval date (September 2000)
Cases with any adverse event
1517
1576
Died
Hospitalized, excluding deaths
397
415
*Ectopic pregnancies
*Experienced blood loss requiring
208
216
transfusions
*Infections
180
186
(Severe infections5)
(33)
(35) The majority these women are included the hospitalized category.
Deaths were associated with sepsis seven cases cases tested positive for Clostridium sordellii,
case tested positive for Clostridium perfringens). All but one fatal sepsis case reported vaginal
misoprostol use; buccal misoprostol use was reported one case. The four remaining U.S. deaths
involved unique events; there was one case each ruptured ectopic pregnancy, methadone overdose,
suspected homicide, and delayed onset toxic shock-like syndrome (uterine cultures were positive for
Peptostreptococcus and fibroid cultures were positive for Prevotella). There were five additional deaths foreign women who used mifepristone for termination pregnancy. One death foreign clinical
trial was associated with septic shock (Clostridium sordellii was identified tissue samples). The other
four foreign deaths were from the post marketing experience and were associated with ruptured gastric
ulcer, uterine hemorrhage, multivisceral failure and thrombotic thrombocytopenic purpura leading
intracranial hemorrhage.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
RCM 2007-525
NDA 20-687
Mifepristone U.S. Postmarketing Adverse Events Summary through 010/31/2009
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the numbers provided here may differ from the numbers the reports that may obtained through
Freedom Information requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end December 2009 approximately 1.23 million
women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
07/31/09
10/31/09
approval date (September 2000)
Cases with any adverse event
1576
1663
Died
Hospitalized, excluding deaths
415
437
*Ectopic pregnancies
*Experienced blood loss requiring
216
227
transfusions
*Infections
186
202
(Severe infections
(35)
(36) The majority these women are included the hospitalized category.
Deaths were associated with sepsis eight cases cases tested positive for Clostridium sordellii,
case tested positive for Clostridium perfringens). All but one fatal sepsis case reported vaginal
misoprostol use; buccal misoprostol use was reported one case. The four remaining U.S. deaths
involved unique events; there was one case each ruptured ectopic pregnancy, methadone overdose,
suspected homicide, and delayed onset toxic shock-like syndrome (uterine cultures were positive for
Peptostreptococcus and fibroid cultures were positive for Prevotella). There were five additional deaths foreign women who used mifepristone for termination pregnancy. One death foreign clinical
trial was associated with septic shock (Clostridium sordellii was identified tissue samples). The other
four foreign deaths were from the post marketing experience and were associated with ruptured gastric
ulcer, uterine hemorrhage, multivisceral failure and thrombotic thrombocytopenic purpura leading
intracranial hemorrhage.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
RCM 2007-525
NDA 20-687
Mifepristone U.S. Postmarketing Adverse Events Summary through 01/31/2010
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the numbers provided here may differ from the numbers the reports that may obtained through
Freedom Information requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end December 2009 approximately 1.23 million
women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
10/31/09
01/31/10
approval date (September 2000)
Cases with any adverse event
1663
1764
Died
Hospitalized, excluding deaths
437
468
*Ectopic pregnancies
*Experienced blood loss requiring
227
252
transfusions
*Infections
202
214
(Severe infections
(36)
(37) The majority these women are included the hospitalized category.
Deaths were associated with sepsis eight cases cases tested positive for Clostridium sordellii,
case tested positive for Clostridium perfringens). All but one fatal sepsis case reported vaginal
misoprostol use; buccal misoprostol use was reported one case. The five remaining U.S. deaths
involved unique events; there was one case each ruptured ectopic pregnancy, substance abuse/drug
overdose, methadone overdose, suspected homicide, and delayed onset toxic shock-like syndrome
(uterine cultures were positive for Peptostreptococcus and fibroid cultures were positive for Prevotella).
There were five additional deaths foreign women who used mifepristone for termination pregnancy.
One death foreign clinical trial was associated with septic shock (Clostridium sordellii was identified tissue samples). The other four foreign deaths were from the post marketing experience and were
associated with ruptured gastric ulcer, uterine hemorrhage, multivisceral failure and thrombotic
thrombocytopenic purpura leading intracranial hemorrhage.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
RCM 2007-525
NDA 20-687
Mifepristone U.S. Postmarketing Adverse Events Summary through 04/30/2010
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the numbers provided here may differ from the numbers the reports that may obtained through
Freedom Information requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end December 2009 approximately 1.23 million
women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
01/31/10
04/30/10
approval date (September 2000)
Cases with any adverse event
1764
1852
Died
Hospitalized, excluding deaths
468
494
*Ectopic pregnancies
*Experienced blood loss requiring
252
267
transfusions
*Infections
214
221
(Severe infections
(37)
(39) The majority these women are included the hospitalized category.
Deaths were associated with sepsis eight cases cases tested positive for Clostridium sordellii,
case tested positive for Clostridium perfringens). All but one fatal sepsis case reported vaginal
misoprostol use; buccal misoprostol use was reported one case. The five remaining U.S. deaths
involved unique events; there was one case each ruptured ectopic pregnancy, substance abuse/drug
overdose, methadone overdose, suspected homicide, and delayed onset toxic shock-like syndrome
(uterine cultures were positive for Peptostreptococcus and fibroid cultures were positive for Prevotella).
There were five additional deaths foreign women who used mifepristone for termination pregnancy.
One death foreign clinical trial was associated with septic shock (Clostridium sordellii was identified tissue samples). The other four foreign deaths were from the post marketing experience and were
associated with ruptured gastric ulcer, uterine hemorrhage, multivisceral failure and thrombotic
thrombocytopenic purpura leading intracranial hemorrhage.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
RCM 2007-525
NDA 20-687
Mifepristone U.S. Postmarketing Adverse Events Summary through 07/31/2010
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the numbers provided here may differ from the numbers the reports that may obtained through
Freedom Information requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end July 2010 approximately 1.35 million
women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
04/30/10
07/31/10
approval date (September 2000)
Cases with any adverse event
1852
1947
Died
Hospitalized, excluding deaths
494
524
*Ectopic pregnancies
*Experienced blood loss requiring
267
287
transfusions
*Infections
221
233
(Severe infections
(39)
(39) The majority these women are included the hospitalized category.
Deaths were associated with sepsis eight cases cases tested positive for Clostridium sordellii,
case tested positive for Clostridium perfringens). All but one fatal sepsis case reported vaginal
misoprostol use; buccal misoprostol use was reported one case. The six remaining U.S. deaths
involved unique events; there was one case each substance abuse/drug overdose, methadone overdose,
suspected homicide, and delayed onset toxic shock-like syndrome (uterine cultures were positive for
Peptostreptococcus and fibroid cultures were positive for Prevotella) and two cases ruptured ectopic
pregnancy. There were five additional deaths foreign women who used mifepristone for termination
pregnancy. One death foreign clinical trial was associated with septic shock (Clostridium sordellii
was identified tissue samples). The other four foreign deaths were from the post marketing experience
and were associated with ruptured gastric ulcer, uterine hemorrhage, multivisceral failure and
thrombotic thrombocytopenic purpura leading intracranial hemorrhage.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
RCM 2007-525
NDA 20-687
Mifepristone U.S. Postmarketing Adverse Events Summary through 10/31/2010
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the numbers provided here may differ from the numbers the reports that may obtained through
Freedom Information requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end July 2010 approximately 1.35 million
women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
07/31/10
10/31/10
approval date (September 2000)
Cases with any adverse event
1947
2036
Died
Hospitalized, excluding deaths
524
555
*Ectopic pregnancies
*Experienced blood loss requiring
287
301
transfusions
*Infections
233
241
(Severe infections
(39)
(40) The majority these women are included the hospitalized category.
Deaths were associated with sepsis eight cases cases tested positive for Clostridium sordellii,
case tested positive for Clostridium perfringens). All but one fatal sepsis case reported vaginal
misoprostol use; buccal misoprostol use was reported one case. The six remaining U.S. deaths
involved unique events; there was one case each substance abuse/drug overdose, methadone overdose,
suspected homicide, and delayed onset toxic shock-like syndrome (uterine cultures were positive for
Peptostreptococcus and fibroid cultures were positive for Prevotella) and two cases ruptured ectopic
pregnancy. There were five additional deaths foreign women who used mifepristone for termination
pregnancy. One death foreign clinical trial was associated with septic shock (Clostridium sordellii
was identified tissue samples). The other four foreign deaths were from the post marketing experience
and were associated with ruptured gastric ulcer, uterine hemorrhage, multivisceral failure and
thrombotic thrombocytopenic purpura leading intracranial hemorrhage.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
Reference ID: 2872972
RCM 2007-525
NDA 20-687
Mifepristone U.S. Postmarketing Adverse Events Summary through 01/31/2011
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the numbers provided here may differ from the numbers the reports that may obtained through
Freedom Information requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end January 2011 approximately 1.46 million
women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
10/31/10
01/31/11
approval date (September 2000)
Cases with any adverse event
2036
2116
Died
Hospitalized, excluding deaths
555
580
*Ectopic pregnancies
*Experienced blood loss requiring
301
315
transfusions
*Infections
241
248
(Severe infections
(40)
(43) The majority these women are included the hospitalized category.
Deaths were associated with sepsis eight cases cases tested positive for Clostridium sordellii,
case tested positive for Clostridium perfringens). All but one fatal sepsis case reported vaginal
misoprostol use; buccal misoprostol use was reported one case. The six remaining U.S. deaths
involved unique events; there was one case each substance abuse/drug overdose, methadone overdose,
suspected homicide, and delayed onset toxic shock-like syndrome (uterine cultures were positive for
Peptostreptococcus and fibroid cultures were positive for Prevotella) and two cases ruptured ectopic
pregnancy. There were five additional deaths foreign women who used mifepristone for termination
pregnancy. One death foreign clinical trial was associated with septic shock (Clostridium sordellii
was identified tissue samples). The other four foreign deaths were from the post marketing experience
and were associated with ruptured gastric ulcer, uterine hemorrhage, multivisceral failure and
thrombotic thrombocytopenic purpura leading intracranial hemorrhage.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
Reference ID: 2909672
RCM 2007-525
NDA 20-687
Mifepristone U.S. Postmarketing Adverse Events Summary through 04/30/2011
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports that have identified, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details,
the numbers provided here may differ from the numbers the reports that may obtained through
Freedom Information requests. These events cannot with certainty causally attributed
mifepristone because information gaps about patient health status, clinical management the patient,
concurrent drug use and other possible medical surgical treatments. The estimated number women
who have used mifepristone the through the end April 2011 approximately 1.52 million
women.
Post-Marketing Adverse Events U.S. Women Who Used Mifepristone for
Termination Pregnancy
Cut off date cumulative reports since
01/31/11
04/30/11
approval date (September 2000)
Cases with any adverse event
2116
2207
Died
Hospitalized, excluding deaths
580
612
*Ectopic pregnancies
*Experienced blood loss requiring
315
339
transfusions
*Infections
248
256
(Severe infections
(43)
(48) The majority these women are included the hospitalized category.
Deaths were associated with sepsis eight cases cases tested positive for Clostridium sordellii,
case tested positive for Clostridium perfringens). All but one fatal sepsis case reported vaginal
misoprostol use; buccal misoprostol use was reported one case. The six remaining U.S. deaths
involved unique events; there was one case each substance abuse/drug overdose, methadone overdose,
suspected homicide, and delayed onset toxic shock-like syndrome (uterine cultures were positive for
Peptostreptococcus and fibroid cultures were positive for Prevotella) and two cases ruptured ectopic
pregnancy. There were five additional deaths foreign women who used mifepristone for termination
pregnancy. One death foreign clinical trial was associated with septic shock (Clostridium sordellii
was identified tissue samples). The other four foreign deaths were from the post marketing experience
and were associated with ruptured gastric ulcer, uterine hemorrhage, multivisceral failure and
thrombotic thrombocytopenic purpura leading intracranial hemorrhage.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the mifepristone labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious infection that has spread beyond the reproductive organs). Not included are women
with reported sexually transmitted infections such Chlamydia infections and gonorrhea, cystitis and
women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
Reference ID: 2950714
RCM 2007-525
NDA 20-687
Mifepristone U.S. Postmarketing Adverse Events Summary through 07/31/2011
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports, and some cases, reclassified
the adverse event terms for individual cases after reviewing the narrative details, the numbers provided
here may differ from the numbers the reports that may obtained through Freedom Information
Act requests. These events cannot with certainty causally attributed mifepristone because
information gaps about patient health status, clinical management the patient, concurrent drug use and
other possible medical surgical treatments. The estimated number women who have used
mifepristone the through the end August 2011 approximately 1.6 million women.
Post-Marketing Adverse Events U.S. Women Who Used
Mifepristone for
Termination Pregnancy
Cut off date cumulative reports
04/30/11
07/31/11
since approval date
(September 2000)
Cases with any adverse event
2207
2292
Died
Hospitalized, excluding deaths
612
641
*Ectopic pregnancies
*Experienced blood loss requiring
339
349
transfusions
*Infections
256
270
(Severe infections5)
(48)
(52) The majority these women are included the hospitalized category.
Deaths were associated with sepsis eight the reported fatalities cases tested positive for
Clostridium sordellii, case tested positive for Clostridium perfringens). All but one fatal sepsis case
reported vaginal misoprostol use; buccal misoprostol use was reported one case. The six remaining
U.S. deaths involved two cases ruptured ectopic pregnancy and one case each substance abuse/drug
overdose, methadone overdose, suspected homicide, and delayed onset toxic shock-like syndrome
(uterine cultures were positive for Peptostreptococcus and fibroid cultures were positive for Prevotella).
There were six additional deaths women from foreign countries (non-US) who used mifepristone for
termination pregnancy. These included one death associated with septic shock (Clostridium sordellii
identified tissue samples) foreign clinical trial, and five deaths identified from post-marketing data
that were associated with ruptured gastric ulcer, uterine hemorrhage, multivisceral failure
thrombotic thrombocytopenic purpura leading intracranial hemorrhage, and toxic shock syndrome
(Clostridium sordellii was identified through uterine biopsy cultures), respectively.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the approved Mifeprex (mifepristone) labeling, bleeding spotting can expected for
average 9-16 days, and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious systemic infection that has spread beyond the reproductive organs). Not included
are women with reported sexually transmitted infections such Chlamydia infections and gonorrhea,
cystitis and women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
Reference ID: 3014147
RCM 2007-525
NDA 20-687
Mifepristone U.S. Postmarketing Adverse Events Summary through 10/31/2011
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports, and some cases, reclassified
the adverse event terms for individual cases after reviewing the narrative details, the numbers provided
here may differ from the numbers the reports that may obtained through Freedom Information
Act requests. These events cannot with certainty causally attributed mifepristone because
information gaps about patient health status, clinical management the patient, concurrent drug use and
other possible medical surgical treatments. The estimated number women who have used
mifepristone the through the end August 2011 approximately 1.6 million women.
Post-Marketing Adverse Events U.S. Women Who Used
Mifepristone for
Termination Pregnancy
Cut off date cumulative reports
07/31/11
10/31/11
since approval date
(September 2000)
Cases with any adverse event
2292
2385
Died
Hospitalized, excluding deaths
641
678
*Ectopic pregnancies
*Experienced blood loss requiring
349
366
transfusions
*Infections
270
279
(Severe infections5)
(52)
(53) The majority these women are included the hospitalized category.
Deaths were associated with sepsis eight the reported fatalities cases tested positive for
Clostridium sordellii, case tested positive for Clostridium perfringens). All but one fatal sepsis case
reported vaginal misoprostol use; buccal misoprostol use was reported one case. The six remaining
U.S. deaths involved two cases ruptured ectopic pregnancy and one case each substance abuse/drug
overdose, methadone overdose, suspected homicide, and delayed onset toxic shock-like syndrome
(uterine cultures were positive for Peptostreptococcus and fibroid cultures were positive for Prevotella).
There were six additional deaths women from foreign countries (non-US) who used mifepristone for
termination pregnancy. These included one death associated with septic shock (Clostridium sordellii
identified tissue samples) foreign clinical trial, and five deaths identified from post-marketing data
that were associated with ruptured gastric ulcer, uterine hemorrhage, multivisceral failure
thrombotic thrombocytopenic purpura leading intracranial hemorrhage, and toxic shock syndrome
(Clostridium sordellii was identified through uterine biopsy cultures), respectively.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the approved Mifeprex (mifepristone) labeling, bleeding spotting can expected for
average 9-16 days, and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious systemic infection that has spread beyond the reproductive organs). Not included
are women with reported sexually transmitted infections such Chlamydia infections and gonorrhea,
cystitis and women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
Reference ID: 3051319
RCM 2007-525
NDA 20-687
Mifepristone U.S. Postmarketing Adverse Events Summary through 1/31/2012
The following information from United States post-marketing reports (i.e., not from clinical trial)
received FDA adverse events that occurred among patients who had taken mifepristone for medical
termination pregnancy. Because FDA has eliminated duplicate reports, and some cases, reclassified
the adverse event terms for individual cases after reviewing the narrative details, the numbers provided
here may differ from the numbers the reports that may obtained through Freedom Information
Act requests. These events cannot with certainty causally attributed mifepristone because
information gaps about patient health status, clinical management the patient, concurrent drug use and
other possible medical surgical treatments. The estimated number women who have used
mifepristone the through the end December 2011 approximately 1.68 million women.
Post-Marketing Adverse Events U.S. Women Who Used
Mifepristone for
Termination Pregnancy
Cut off date cumulative reports
10/31/11
01/31/12
since approval date
(September 2000)
Cases with any adverse event
2385
2475
Died
Hospitalized, excluding deaths
678
705
*Ectopic pregnancies
*Experienced blood loss requiring
366
380
transfusions
*Infections
279
289
(Severe infections5)
(53)
(56) The majority these women are included the hospitalized category.
Deaths were associated with sepsis eight the reported fatalities cases tested positive for
Clostridium sordellii, case tested positive for Clostridium perfringens). All but one fatal sepsis case
reported vaginal misoprostol use; buccal misoprostol use was reported one case. The six remaining
U.S. deaths involved two cases ruptured ectopic pregnancy and one case each substance abuse/drug
overdose, methadone overdose, suspected homicide, and delayed onset toxic shock-like syndrome
(uterine cultures were positive for Peptostreptococcus and fibroid cultures were positive for Prevotella).
There were six additional deaths women from foreign countries (non-US) who used mifepristone for
termination pregnancy. These included one death associated with septic shock (Clostridium sordellii
identified tissue samples) foreign clinical trial, and five deaths identified from post-marketing data
that were associated with ruptured gastric ulcer, uterine hemorrhage, multivisceral failure
thrombotic thrombocytopenic purpura leading intracranial hemorrhage, and toxic shock syndrome
(Clostridium sordellii was identified through uterine biopsy cultures), respectively.
Administration mifepristone and misoprostol contraindicated patients with confirmed
suspected ectopic pregnancy pregnancy outside the uterus). stated the approved Mifeprex (mifepristone) labeling, bleeding spotting can expected for
average 9-16 days, and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease
(involving the nearby reproductive organs such the fallopian tubes ovaries), and pelvic infections
with sepsis serious systemic infection that has spread beyond the reproductive organs). Not included
are women with reported sexually transmitted infections such Chlamydia infections and gonorrhea,
cystitis and women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review
the case details. Severe infections generally involve death hospitalization for least 2-3 days,
intravenous antibiotics for least hours, total antibiotic usage for least days, and any other
physical clinical findings, laboratory data surgery that suggest severe infection.
Reference ID: 3093905
RCM 2007-525
NDA 20-687
Mifepristone U.S. Postmarketing Adverse Events Summary through 04/30/2012
Mifepristone FDA approved for the medical termination intrauterine pregnancy through
days pregnancy (Mifeprex, 2000) and control high blood sugar levels (hyperglycemia) adults with
endogenous Cushing syndrome (Korlym, 2012). The following information from United States post-marketing
reports (i.e., not from clinical trial) received FDA adverse events that occurred among patients who had
taken mifepristone for medical termination pregnancy. Because FDA has eliminated duplicate reports, and
some cases, reclassified the adverse event terms for individual cases after reviewing the narrative details, the
numbers provided here may differ from the numbers the reports that may obtained through Freedom
Information Act requests. These events cannot with certainty causally attributed mifepristone because
information gaps about patient health status, clinical management the patient, concurrent drug use and other
possible medical surgical treatments. The estimated number women who have used Mifeprex the
through the end December 2011 approximately 1.68 million women.
Post-Marketing Adverse Events U.S. Women Who Used
Mifepristone for
Termination Pregnancy
01/31/12
04/30/12
Cut off date cumulative reports
since approval date
(September 2000)
Cases with any adverse event
2475
2570
Died
Hospitalized, excluding deaths
705
730
*Ectopic pregnancies
*Experienced blood loss requiring
380
392
transfusions
*Infections
289
293
(Severe infections5)
(56)
(56) The majority these women are included the hospitalized category.
Deaths were associated with sepsis eight the reported fatalities cases tested positive for Clostridium sordellii,
case tested positive for Clostridium perfringens). All but one fatal sepsis case reported vaginal misoprostol use; buccal
misoprostol use was reported one case. The six remaining U.S. deaths involved two cases ruptured ectopic pregnancy and
one case each substance abuse/drug overdose, methadone overdose, suspected homicide, and delayed onset toxic shocklike syndrome (uterine cultures were positive for Peptostreptococcus and fibroid cultures were positive for Prevotella). There
were seven additional deaths women from foreign countries (non-US) who used mifepristone for termination pregnancy.
These included one death associated with septic shock (Clostridium sordellii identified tissue samples) foreign clinical
trial, and one death associated with sepsis reported foreign regulatory agency (not confirmed), and five deaths identified
from post-marketing data that were associated with ruptured gastric ulcer, uterine hemorrhage, multivisceral failure
thrombotic thrombocytopenic purpura leading intracranial hemorrhage, and toxic shock syndrome (Clostridium sordellii was
identified through uterine biopsy cultures) respectively.
Administration mifepristone and misoprostol contraindicated patients with confirmed suspected ectopic pregnancy pregnancy outside the uterus). stated the approved Mifeprex (mifepristone) labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease (involving the nearby
reproductive organs such the fallopian tubes ovaries), and pelvic infections with sepsis serious systemic infection that
has spread beyond the reproductive organs). Not included are women with reported sexually transmitted infections such
Chlamydia infections and gonorrhea, cystitis and women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review the case details.
Severe infections generally involve death hospitalization for least 2-3 days, intravenous antibiotics for least hours,
total antibiotic usage for least days, and any other physical clinical findings, laboratory data surgery that suggest
severe infection.
Reference ID: 3138272
RCM 2007-525
NDA 20-687
Mifepristone U.S. Postmarketing Adverse Events Summary through 10/31/2012
Mifepristone FDA approved for the medical termination intrauterine pregnancy through
days pregnancy (2000) and control high blood sugar levels (hyperglycemia) adults with endogenous
Cushing syndrome (2012). The following information from United States post-marketing reports (i.e., not from clinical trial) received FDA adverse events that occurred among patients who had taken mifepristone for
medical termination pregnancy. Because FDA has eliminated duplicate reports, and some cases, reclassified
the adverse event terms for individual cases after reviewing the narrative details, the numbers provided here may
differ from the numbers the reports that may obtained through Freedom Information Act requests. These
events cannot with certainty causally attributed mifepristone because information gaps about patient health
status, clinical management the patient, concurrent drug use and other possible medical surgical treatments.
The estimated number women who have used mifepristone the for termination pregnancy through the
end October 2012 approximately 1.88 million women.
Post-Marketing Adverse Events U.S. Women Who Used
Mifepristone for
Termination Pregnancy
Cut off date cumulative reports
04/30/12
10/31/12
since approval date
(September 2000)
Cases with any adverse event
2570
2740
Died
Hospitalized, excluding deaths
730
768
*Ectopic pregnancies
*Experienced blood loss requiring
392
416
transfusions
*Infections
293
308
(Severe infections5)
(56)
(57) The majority these women are included the hospitalized category.
Deaths were associated with sepsis eight the reported fatalities cases tested positive for Clostridium sordellii,
case tested positive for Clostridium perfringens). All but one fatal sepsis case reported vaginal misoprostol use; buccal
misoprostol use was reported one case. The six remaining U.S. deaths involved two cases ruptured ectopic pregnancy and
one case each substance abuse/drug overdose, methadone overdose, suspected homicide, and delayed onset toxic shocklike syndrome (uterine cultures were positive for Peptostreptococcus and fibroid cultures were positive for Prevotella). There
were seven additional deaths women from foreign countries (non-US) who used mifepristone for termination pregnancy.
These included one death associated with septic shock (Clostridium sordellii identified tissue samples) foreign clinical
trial, and one death associated with sepsis reported foreign regulatory agency (not confirmed), and five deaths identified
from post-marketing data that were associated with ruptured gastric ulcer, uterine hemorrhage, multivisceral failure
thrombotic thrombocytopenic purpura leading intracranial hemorrhage, and toxic shock syndrome (Clostridium sordellii was
identified through uterine biopsy cultures) respectively.
Administration mifepristone and misoprostol contraindicated patients with confirmed suspected ectopic pregnancy pregnancy outside the uterus). stated the approved Mifeprex (mifepristone) labeling, bleeding spotting can expected for average 9-16 days,
and may last for days.
This category includes endometritis (involving the lining the womb), pelvic inflammatory disease (involving the nearby
reproductive organs such the fallopian tubes ovaries), and pelvic infections with sepsis serious systemic infection that
has spread beyond the reproductive organs). Not included are women with reported sexually transmitted infections such
Chlamydia infections and gonorrhea, cystitis and women with toxic shock syndrome not associated with pelvic infection.
This subset infections includes cases that were determined severe based medical review the case details.
Severe infections generally involve death hospitalization for least 2-3 days, intravenous antibiotics for least hours,
total antibiotic usage for least days, and any other physical clinical findings, laboratory data surgery that suggest
severe infection.
Reference ID: 3233166
RCM 2007-525
NDA 20-687
Mifepristone U.S. Postmarketing Adverse Events Summary through 04/30/2014
The following information from United States post-marketing reports (i.e., not from clinical
trial) received FDA adverse events that occurred among patients who had taken
mifepristone for medical termination pregnancy. Because FDA has eliminated duplicate
reports, and some cases, reclassified the adverse event terms for individual cases after
reviewing the narrative details, the numbers provided here may differ from the numbers the
reports that may obtained through Freedom Information Act requests. These events
cannot with certainty causally attributed mifepristone because information gaps about
patient health status, clinical management the patient, concurrent drug use and other
possible medical surgical treatments and conditions. The estimated number women who
have used mifepristone the for the medical termination pregnancy through the end
April 2014 approximately 2.26 million women, increase approximately 380,000 since
October 2012.
Table Post-Marketing Adverse Events U.S. Women Who Used
Mifepristone for Medical Termination Pregnancy
Date range cumulative reports
09/28/00 04/30/14
Died
*Ectopic pregnancies The majority these women are included the hospitalized category Table
U.S. approval date
Table Post-Marketing Adverse Events U.S. Women Who Used