The FDA has issued a public safety announcement for mefloquine, an anti-malarial drug also known by the band name Lariam. The drug will now carry a “black box” warning – the most serious warning the FDA issues.
Mefloquine has been used by U.S. troops for years, and is also available to civilians traveling to “hot spots”. It was developed by the US Army and became available on the commercial market in 1989. It is one of the most commonly prescribed anti-malarial drugs in the U.S., with about 119,000 prescriptions written in the first half of 2013.
The FDA warning about the mefloquine was issued on July 29, 2013 in a public safety announcement, which states:
FDA is advising the public about strengthened and updated warnings regarding neurologic and psychiatric side effects associated with the antimalarial drug mefloquine hydrochloride. A boxed warning, the most serious kind of warning about these potential problems, has been added to the drug label.
FDA has revised the patient Medication Guide dispensed with each prescription and wallet card to include this information and the possibility that the neurologic side effects may persist or become permanent. The neurologic side effects can include dizziness, loss of balance, or ringing in the ears. The psychiatric side effects can include feeling anxious, mistrustful, depressed, or having hallucinations.
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.
Mefloquine has been implicated in cases of violence among military personnel, with the most notable case being that of Staff Sergeant Robert Bales, who pleaded guilty in June to killing 16 Afghan citizens in 2012. His sentencing trial begins in August 2013.
The possibility that Sgt. Bales was given mefloquine while in Afghanistan and Iraq was raised earlier this month when the FDA released an adverse event notification filed by an anonymous pharmacist in 2012. The notification states that an unnamed soldier who took the drug murdered 17 Afghan citizens – the same number included in Bales’ initial charging documents.
The adverse event notification report was obtained by Military Times on July 5 via the Freedom of Information Act. It states:
It was reported that this patient was administered mefloquine in direct contradiction to US military rules that mefloquine should not be given to soldiers who had suffered traumatic brain injury due to its propensity to cross blood-brain barriers inciting psychotic, homicidal, or suicidal behavior.
An FDA adverse event report means that a patient developed symptoms while using a drug, but does not necessarily mean the medication caused any specific health problems. However, the medically confirmed report does suggest that either the source of the notification was someone who was directly involved with the patient’s medical care or that the drug manufacturer received documentation verifying the information, according to Dr. Remington Nevin, a leading mefloquine researcher who has also filed a FOIA request for the information.