FDA orders revised drug warning for epilepsy drug

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Story last updated at 1:02 a.m. Friday, July 11, 2003

FDA orders revised drug warning for epilepsy drug

WASHINGTON (AP) -- The government has ordered more detailed information to be provided with an epilepsy drug that did not warn about decreased sweating and hyperthermia.

The order for updated information on Topamax is based on clinical trials and the experience of more than 2 million users worldwide, the Food and Drug Administration said Thursday.

Most of the reports of problems have involved children. Most cases have occurred in connection with exposure to hot temperatures, vigorous activity or both. Children using the medication should be closely observed under these conditions, the FDA said.

The FDA said potential cases of decreased sweating were observed in about 35 per 1 million Topamax patients; 1.6 users per 1 million had serious problems with it.

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