Black Box Added to Antimalarial Drug Mefloquine Hydrochloride (Lariam) for Neurological Side Effects

Washington, DC: The US Food and Drug Administration (FDA) is advising the public about strengthened and updated warnings regarding neurologic and psychiatric side effects associated with the antimalarial drug mefloquine hydrochloride (Lariam). A boxed warning, the most serious kind of warning about these potential problems, has been added to the drug label.

The neurologic side effects, which may persist or become permanent, 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. Patients, caregivers, and health care professionals should watch for these side effects.

Malaria is a serious disease caused by a parasite that commonly infects mosquitoes, which then bite humans. It is a major cause of death worldwide but is less common in the United States. The disease is a problem primarily in developing countries with warm climates.

Persons who travel to these countries, including the military, may be at risk of malaria infection and are prescribed the drug to prevent contracting the disease.

Mefloquine was developed by the United States Army, and became commercially available in 1989. Roche, the brand-name manufacturer, no longer sells Lariam in the United States, but generic versions are available.

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Last updated on Aug-1-13