FDA Warns of Serious Symptoms Caused by Drug Army Gave Sgt.

It took more than a year for the Food and Drug Administration (FDA) to finally issue a stern warning about the serious neurological and psychiatric side effects associated with a controversial antimalarial drug that the U.S. Army gave a sergeant before he snapped.

The drug is mefloquine hydrochloride and we now know that the Army gave it to 39-year-old Sergeant Robert Bales in contradiction to guidelines. Last spring Bales, a respected soldier and father on his fourth deployment in a decade, attacked and murdered 16 Afghan civilians. It came as a shock to many because Bales was an otherwise “affable” man who became uncharacteristically psychotic and aggressive, a change common among those treated with mefloquine.

Last month the veteran sergeant pled guilty, revealing in his military court hearing that he couldn’t explain why he did it. “I’ve asked that question a million times since then, and there’s not a good reason in the world for why I did the horrible things I did,” he told the military judge. Bales’ lawyer has confirmed that he took mefloquine during at least three of his deployments to treat malaria, which is common in developing countries and is transmitted to humans by parasite-infected mosquitos.   

This means the Army certainly has some culpability in the massacre. Judicial Watch has investigated this case for more than a year and uncovered government records that prove the Department of Defense (DOD) has long been well versed on mefloquine’s serious side effects. That’s why in 2009 the DOD removed mefloquine as the drug of choice in the treatment of malaria. Furthermore, the drug is specifically prohibited in the treatment of patients with head injuries, and in particular, a traumatic brain injury (TBI). It is also contraindicated for patients with post-traumatic stress disorder.

Bales suffered a traumatic brain injury in Iraq in 2010 and DOD policy would have prohibited administering the drug to the sergeant. Judicial Watch has also obtained FDA records detailing more than 2,000 episodes of adverse reactions to mefloquine during a 15-year span, including 87 deaths associated with the drug. Of the deaths, 39 were recorded as suicides by the agency and a dozen as homicides.

DOD records obtained by JW show that, despite its own directive to limit use of the drug, the agency continues buying large quantities. Since 2010 the Pentagon bought 2,250,925 mefloquine tablets at a cost of $5,487,130, according to the records obtained by JW from the Defense Logistics Agency. Nevertheless, the DOD has refused to confirm or deny if Bales took mefloquine while he served.

Perhaps this week’s FDA warning will carry enough weight to convince the Pentagon to stop giving our soldiers this dangerous pill. “Neurologic side effects can occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent,” the FDA warning reads. The agency says the new “boxed warning” is the most serious kind of warning added to the drug’s label.