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Wednesday, July 9, 2003
Anti-Malaria Pill Comes With Risk Guide

WASHINGTON (AP) - People prescribed Lariam to prevent malaria before a trip abroad will now get a government-ordered brochure along with the pills describing what to do if some rare but serious side effects strike.

The FDA announced Wednesday that every Lariam prescription now will come with a medication guide that explains its pros and cons in consumer-friendly language.

The new warnings stress that some people shouldn't take the drug: those with active or recent depression, a history of other psychiatric disorders, or epilepsy.

The guide also advises patients who suddenly experience psychiatric side effects to promptly contact a doctor - they may need to stop the Lariam and switch to another anti-malaria pill.

Last year, the FDA strengthened warnings on the drug's label that it can cause some rare but potentially serious psychiatric side effects, ranging from anxiety and dreams to hallucinations, depression, occasionally even psychotic behavior.

FDA's Dr. Leonard Sacks said the new guide addresses concerns that the information was still not reaching those who need it. About 800 Americans a year return home infected with malaria, most because they didn't know to take the pills or skipped them from worry about side effects.

Most of the several million Americans who travel to malaria-plagued countries come home healthy thanks to one of several protective drugs. Lariam is the most prescribed among them.

The guide will not imply that Lariam is a worse choice than other anti-malaria pills, Sacks said. Each has side effects, and Lariam has advantages that make it an important option.