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Roche Will Alert Physicians of Possible Mental Side-Effects From Malaria Drug

Sep 4, 2002 | Dow Jones Newswires The maker of a popular malaria-prevention drug, prescribed to thousands of U.S. travelers and military personnel, is planning to send notices to doctors and other health-care professionals noting that a small number of people have committed suicide after taking it, Wednesday's Wall Street Journal reported.

The drug Lariam, made by Roche Holding AG , is one of several medicines for physical ailments that have in recent years been reported to have worrisome psychiatric side effects. Some drugs for acne, arthritis, asthma, even some antibiotics have been reported to cause depression, anxiety and other types of emotional instability. While the vast number of people who take the drugs do fine with them, these rare side effects can be particularly scary.

Revisions to drug labels are fairly common, but Roche's new action may highlight potential side effects beyond the fine-print on a label. It comes as new questions are being raised about Lariam after army investigators said that they would examine whether the drug was one factor in a series of widely publicized murders and suicides by soldiers this summer in Fort Bragg, N.C. Investigators have yet to establish a direct link to the tragedies.

Roche and the federal Food and Drug Administration say that no link has been made between any suicides and Lariam. But in July, after ongoing discussions with the FDA, Roche changed the drug's label and official product information to acknowledge "rare cases of suicidal ideation and suicide have been reported." Now it plans to publicize the move by sending written notices to thousands of doctors around the U.S.

"If symptoms of acute anxiety, depression and confusion occur," the new label says, they could lead "to a more serious event." In such case, patients should quit the drug and take another malaria medicine.

Lariam, which has been prescribed to 25 million people world-wide since its introduction in 1985, is one of the most effective prevention treatments for malaria, one of the world's most deadly infectious diseases. 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 to increasingly trendy Third World destinations, as well as with Peace Corps volunteers and aid workers. Most have experienced only mild or no side effects.

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