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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