On July 29, 2013, the U.S. Food and Drug Administration (FDA) started advising the public that warnings regarding the neurologic and psychiatric side effects associated with the antimalarial drug Lariam (generic: mefloquine hydrochloride) have been updated to highlight the fact that some of the drug’s side effects may persist or even become permanent. Neurologic side effects can include dizziness, loss of balance, or ringing in the ears. Psychiatric side effects can include anxiety, feeling mistrustful or depressed, or having hallucinations. A Black Box warning, the most serious kind of warning about potential side effect problems, has been added to the drug’s label.
Previously, Lariam had been linked to serious psychiatric side effects, including suicide. Still, the drug is prescribed to thousands of U.S. travelers and military personnel.
Roche, the manufacturer of Lariam, started taking steps before the recent FDA effort. The company sent notices to doctors and other health-care professionals warning of the risk of suicide. The warnings came after new questions were raised about Lariam when army investigators said that they would examine whether the drug was a factor in a series of widely publicized murders and suicides by soldiers in Fort Bragg, North Carolina.
Roche also changed the drug’s label and official product information to acknowledge that rare cases of suicidal ideation and suicide have been reported. If symptoms of acute anxiety, depression and confusion occur, the new label said, they could lead to a more serious event. In such cases, patients should quit the drug and take another malaria medicine.
The U.S. Centers for Disease Control and Prevention recommends Lariam as the drug standard in 79 countries where malaria is resistant to other drugs. Developed by the U.S. army and later licensed to Roche, the drug was first tested and used primarily among the military. But it has grown popular with many U.S. tourists traveling to increasingly trendy Third World destinations, as well as with Peace Corps volunteers and aid workers. Since its introduction in 1985, Lariam has been prescribed to an estimated 25 million people worldwide.