Judicial Watch • Food and Drug Administration

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Anti-Malarial Drug Mefloquine Associated With 87 Deaths and Hundreds of Psychotic Episodes in Past 15 Years

Was Staff Sergeant Robert Bales Administered the Drug?

(Washington, DC) — Judicial Watch, the public interest group that that investigates and fights government corruption, announced today that it has uncovered documents from the Food and Drug Administration (FDA) detailing more than 2,000 episodes during the past 15 years in which people had serious adverse reactions caused by the anti-malaria drug, mefloquine hydrochloride, commonly known as Lariam®.  Of 87 reported deaths associated with the drug, 39 were recorded as suicides and 12 were homicides.

The documents obtained by Judicial Watch pursuant to a March 26, 2012, request submitted to the FDA, include details from the agency’s Adverse Event Reporting System (AERS) identifying persons treated with mefloquine from November 4, 1997, through March 28, 2012, and the specific reported reactions to the drug. In addition to the reported deaths, reported reactions included hallucinations, panic attacks, depression, paranoia, anxiety, confusion, mental disorder, delusion, hemorrhaging, and numerous other serious disorders.

Long known for its severe neurological side effects, mefloquine was supposedly removed as the drug of choice in the treatment of malaria by the Department of Defense (DOD). In a September 2009 policy memorandum, the Defense Department stated that mefloquine was to be prescribed only in limited cases where other drugs, such as doxycycline and mallarone, were considered unlikely to be effective. Mefloquine was specifically prohibited in the treatment of patients with head injuries, and in particular, a TBI (traumatic brain injury).  It is also contraindicated for patients with post-traumatic stress disorder.

Nonetheless, the documents obtained by Judicial Watch indicate clearly that mefloquine is still prescribed, even though its use has decreased since the September 2009 memorandum limiting its use was issued. In the field, medics apparently do not necessarily need to follow such policy recommendations by the U.S. Army and U.S. Central Command (CENTCOM).

Given the serious side effects of the drug and the psychotic and aggressive change that can occur in the personality of patients being treated with mefloquine, questions have been raised as to whether or not Staff Sergeant Robert Bales was given the drug prior to his allegedly attacking and murdering 17 Afghan civilians during the night of March 11, 2012.

To date, the DOD has neither confirmed nor denied that Sergeant Bates took mefloquine, citing medical privacy concerns. His attorney, John Henry Browne, told CNN that he “would not be surprised” if Bales took it. According to The Huffington Post: “The Pentagon is in the midst of a widespread review of the military’s use of a notorious anti-malaria drug after finding out that the pills have been wrongly given to soldiers with preexisting problems, including brain injuries such as the one sustained by the U.S. soldier who allegedly massacred 17 civilians in Afghanistan…[T]he initial review was ordered in January. After the massacre, on March 20, one part of the Army issued an urgent call to complete the Jan. 17 request from Woodson within six days.”

Bales reportedly suffered a traumatic brain injury in Iraq in 2010.  If so, then Defense Department policy would have prohibited administration of the drug to Bales.

“Obviously, the Department of Defense has been lax in policing the use of this dangerous drug in the treatment of service men and women,” said Tom Fitton, president of Judicial Watch. “Given the seriousness of the side effects documented in these reports, the Pentagon should quickly considering halting the drug’s distribution to our troops.”

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