Background

In an effort to appease radical pro-abortion activists, the Clinton Food and Drug Administration hastily approved the abortion pill, RU-486, on September 28, 2000. Judicial Watch immediately filed a FOIA request and then battled the government in court to force the release of documents pertaining to the decision to approve the drug. JW learned through the document release that the FDA approved RU-486 under the "Accelerated Approval of New Drugs for Serious or Life-threatening Illnesses," a measure intended to apply to drugs for illnesses such as cancer and AIDS. (This, of course, was completely inappropriate given the fact that RU-486 does not treat any illness, serious or otherwise. It is designed for the expressed purpose of terminating life.) Judicial Watch also uncovered clinical trials that revealed serious health complications resulting from the use of the drug, including internal bleeding and the passing of large blood clots. Recent press reports linking the deaths of two UK women to RU-486 prompted JW to once again file open records requests and forced the release of government documents relating to the matter. The following medical report obtained by JW from the Center for Drug Evaluation and Research contains the medical history of one of the UK women who died after using the drug. (Warning: The following information contains some graphic medical details.)

Key Excerpts

Food and Drug Administration Medical Products Report, June 4, 2002:

• "A female patient (age unknown) was treated with misoprostol (dose unknown) by mouth on [date withheld] for abortion. On [date withheld] she was given misoprostol 800 g per vagina, plus another drug (possible mifepristone). The patient was also given 1 g of antibiotics for any possible infection and paracetamol for pain relief. The termination went well and the patient was fine on [date withheld.]"
• "In the night, the patient went to a nightclub. She complained of pain in her leg, headache and racing heart. She collapsed at the nightclub and was hospitalized. The patient died soon after..."
• "On [date withheld] autopsy revealed 1 liter of blood in the patient's stomach and two gastric ulcers. The coroner is now looking at the drugs given for the termination, which could have possibly caused a heart problem and thrombotic events."

Relevance

Despite the best attempts of radical pro-abortion activists and the Clinton administration to paint RU-486 as a harmless and effective drug, these documents tell a different story. The autopsy of the UK woman who died the same day she was treated with the drug reveals a pattern of symptoms consistent with clinical studies that proved RU-486 to be a dangerous, and potentially lethal, drug for the women who take it. These clinical studies were available to the Clinton administration prior to its approval of RU-486, which begs the question: Did Bill Clinton and his political appointees at the Food and Drug Administration put their political interests ahead of the health and well-being of thousands of women and unborn children? JW will continue to investigate RU-486 and educate the public about its dangerous and deadly side effects, while also pressuring the Bush administration to review the safety and effectiveness of the drug.