A National Academy of Sciences, Engineering and Medicine committee will conduct a review of the long-term health effects of an anti-malarial drug taken by U.S. troops that has been linked to brain damage and psychiatric disorders.
The committee on Jan. 28 will launch an 18-month study of mefloquine, also known by its brand name, Lariam, and other malaria medications used by military personnel, Peace Corps volunteers and State Department employees over the past several decades.
U.S. troops have taken a variety of medications, including mefloquine, malarone, doxycycline and chloroquine, to prevent malaria in countries where it is prevalent, such as Afghanistan and Iraq.
The committee plans to examine the possible long-term health consequences of taking these medications, with a special focus on mefloquine and its potential "neurological effects, long-term psychiatric effects and the potential development of post-traumatic stress disorder."
Mefloquine, developed by the U.S. Army at the Walter Reed Army Institute of Research in the 1970s, was commercially introduced in 1989 as a once-a-week medication for preventing malaria. It is also used to treat the mosquito-borne parasite. Shortly after the drug's introduction under the brand name Lariam, some users reported experiencing hallucinations, nightmares, psychosis and delirium after taking it.
Mefloquine remained in widespread use by the U.S. military until 2009, when Pentagon officials, responding to concerns over the neurological side effects, issued a policy listing it as a last-choice preventive in areas where malaria strains are resistant to other available medications.
Four years later, the FDA placed its strongest warning on mefloquine, saying the drug can cause ongoing or permanent neurological and psychiatric conditions, including dizziness, loss of balance, tinnitus, anxiety, depression, paranoia and hallucinations, even after discontinuing use.
Case studies have shown that neurological damage related to mefloquine use has symptoms similar to PTSD. In 2016, an Army physician published a case study of a 32-year-old service member who had been diagnosed with PTSD but also had cognitive issues and vertigo. His physicians linked his symptoms to mefloquine after other treatments failed.
In December, a former Navy SEAL filed a lawsuit against Roche, the manufacturer of Lariam, alleging that the drug made him permanently disabled. The suit alleges that the pharmaceutical company knew that the drug caused serious side effects and failed to warn patients.
An article published in June in the American Journal of Tropical Medicine and Hygiene by VA researchers Aaron Schneiderman, director of post-deployment health services at the VA, and Robert Bossarte, also with VA post-deployment health services, found that while "antimalarial use was generally associated with higher odds of negative health outcomes," once other variables, including combat exposure, were considered, "no significant associations were found between mefloquine" and five studied mental health conditions.
At the peak of mefloquine's use by the U.S. military in 2003, military doctors wrote more than 53,000 prescriptions for the drug.
From 1989 to September 2018, the FDA received 3,742 reports of adverse effects associated with mefloquine, 3,452 of which were labeled as serious. An adverse event report does not indicate that the drug caused the observed side effect. It simply denotes that the medication had been taken at some point before an adverse event occurred.
According to the FDA's Adverse Event Reporting System, some of the events following mefloquine use to prevent malaria included seizures, mania, depression, suicidal thoughts, hallucinations, suicide and six cases of homicide.
Dr. Remington Nevin, a former Army preventive medicine officer, researcher and executive director of The Quinism Foundation, a group dedicated to supporting research on the effects of quinoline drugs, including mefloquine, said he will speak on the topic during the committee's public forum session but has concerns regarding the timing of the study, which is being conducted at the request of the Department of Veterans Affairs.
Nevin said that since the FDA already has acknowledged that mefloquine can cause severe, permanent side effects, the VA should be screening veterans who took the medication and providing treatment and disability compensation to them instead of asking for additional study.
"I'm concerned that this study is being undertaken in bad faith by the VA to delay action on this issue ... or worse, manufacture doubt about the significance and magnitude of the problem," Nevin said. "If the VA is genuinely interested in this topic, it should be preparing, at the very least, to screen veterans to determine who has been exposed."
A portion of the committee's two-day opening session will be open to the public. It also will be streamed via a webcast; however, registration is required for in-person and webcast attendance.
For more information or to register, go to the National Academy of Sciences Engineering and Medicine website.
-- Patricia Kime can be reached at patricia.kime@military.com. Follow her on Twitter @patriciakime.
