This is the Association of the United States Navy’s policy position on mefloquine toxicity, included in written testimony for the record to a recent Joint Hearing of the House and Senate Veterans’ Affairs Committee.

Written Testimony for the Record by the

ASSOCIATION OF THE UNITED STATES NAVY

Submitted to the

HOUSE AND SENATE COMMITTEES ON VETERANS’ AFFAIRS

for the

JOINT HEARING OF THE HOUSE AND SENATE
VETERANS’ AFFAIRS COMMITTEE

Submitted by

Garry E. Hall

Rear Admiral, USN (Ret)

National Executive Director

ASSOCIATION OF THE UNITED STATES NAVY

3 March  2016

MEFLOQUINE TOXICITY

Issue: Over the last 10 years, it has become increasingly clear that the use of mefloquine is accompanied by a greatly increased risk of severe neurological damage. The drug mefloquine hydrochloride (previously marketed as Lariam®) is an anti-malarial drug that was developed by the U.S. military during the 1970s at the Walter Reed Army Institute of Research (WRAIR) as a replacement for chloroquine. Since its introduction mefloquine has been widely provided to U.S. Special Forces and to hundreds of thousands of troops on large deployments including to Somalia, Iraq, and Afghanistan. Mefloquine has a history of causing disturbing side effects, the severity of which is only now becoming apparent.

AUSN’s Position: AUSN recommends ceasing the distribution of mefloquine to service members for the prevention of malaria, except in cases of declared national emergency where the distribution is absolutely necessary. We also recommend Congress establish legislation requiring DoD to report on the availability of mefloquine alternatives, and the progress of all scientific studies on the drug’s toxicity and to estimate of the number of service members previously exposed to the drug. Additionally, we support DoD’s expansion of the mission of the Hearing Center of Excellence, the Vision Center of Excellence and the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury to include diagnosis and management of service members suffering detrimental effects of mefloquine. Lastly, DoD needs to develop and implement policies to effectively evaluate military disability claims regarding adverse effects of mefloquine exposure.

Background: As early as 1973 in the first human Phase I trials, researchers found that mefloquine was associated with transient dizziness. By 1981, vertigo accompanied by confusion had been noted in Phase II trials. By 1983, serious psychiatric effects including hallucinations, disorientation and transient confusion were commonly reported. By the time of mefloquine’s U.S. licensure in 1989, the product insert emphasized the risk of, “dizziness, and disturbed sense of balance or neuropsychiatric reactions,” and warned, “If signs of unexplained anxiety, depression, restlessness or confusion are noticed, these may be considered prodromal to a more serious event.” By 1994, the U.S. product insert warned of risk of, “encephalopathy of unknown etiology,” and that dizziness and psychiatric effects could continue even after therapy. By 2008, following reports of persistent vertigo lasting as long as 12 months, the U.S. product insert was updated to warn that in, “a small number of patients, dizziness and loss of balance have been reported to continue months after mefloquine has been stopped.”

In 2012, at a Senate Appropriations Subcommittee on Defense, testimony was offered that toxicity of mefloquine was the “third signature injury” of modern war, alongside post-traumatic stress disorder (PTSD) and Traumatic Brain Injury (TBI). Additionally, the Center for Disease Control stated that “along with the problems the drug can directly cause, it can also, “confound the diagnosis and management of PTSD and TBI.”

Recently, the dangers of mefloquine exposure has been further brought to light with DoD’s decision on April13, 2013 to revise and update their Guidance on Medications for Prophylaxis of Malaria to sharply restrict the use of the drug and label it as a “last resort” drug. These concerns were further amplified by the FDA’s decision on July 29, 2013 to require a black box label on mefloquine, warning of a risk of serious psychiatric and neurologic effects, some of which could be permanent.

Fortunately, the last decade has seen the development of multiple safe and effective alternatives to mefloquine. In acknowledgement of the availability of safer drugs, on September 13, 2013 the U.S. Army’s Special Operations Command (USASOC) issued specific orders prohibiting the use of the drug outright. However the drug otherwise remains available for use across the military services, and few resources are available to help those suffering its long-term effects.