The Food and Drug Administration ordered manufacturers of mefloquine hydrochlorideto give the medicine a black box label, the agency's strongest warning, reserved fordrugs with significant risks of serious side effects.
The FDA said that some neurological and psychiatric side effects can last for months or years after a patient stops taking the drug.
The medication was approved by the FDA in 1989 under the brand name Larium andquickly became a leading drug for preventing and treating malaria — among travelersand the military.While other drugs must be taken daily, one tablet a week of mefloquine offers protectionagainst the sometimes-deadly mosquito-borne parasite, including against strains that areresistant to other medications.But the drug has long carried warnings tying it to dizziness, seizures, insomnia, anxiety,depression and strange dreams. One clinical trial found that 29% of travelers who tookmefloquine experienced at least one of those side effects. There is also evidence suggesting a link to violent behavior, including suicide.Amid growing concerns, the drug fell out of favor over the last decade. Roche, itsoriginal manufacturer, stopped selling Larium in the U.S. in 2008. The generic versionsstill on the market accounted for 226,000 of the 5.4 million U.S. prescriptions for anti-malaria drugs last year, according to IMS Health, which tracks drug trends. The Pentagon, which used the drug widely in Somalia and during the early years of thewars in Iraq and Afghanistan, offered little explanation when it began scaling back itsreliance on mefloquine and eventually recommended that the drug be used only as athird choice.Military officials continued to dismiss the claims of veterans who insisted that the sideeffects could be long-lasting.
The new FDA warning provided those veterans a sense of validation."I almost fell out of my chair when (the news) was forwarded to me," said Greg Alderete, a retired Army lieutenant colonel who blames his chronic balance andmemory problems on the drug, which he took while serving in Somalia in 1993.
Alderete said that in 2008 he started to suspect mefloquine after connecting with otherveterans of Somalia who were experiencing similar symptoms.He eventually helped launch a Facebook group, Veterans Against Larium, which nowhas more than 1,100 members. He said most served in Somalia, but the group has alsoattracted veterans from other wars.Alderete acknowledged that his depression, anger and anxiety could be the result of post-traumatic stress disorder, with which he was diagnosed. But his chronic dizzinessand nausea and an inability to remember words are less easily explained.