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U.S. Department of Health and Human Services


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Topamax (topiramate) Tablets, Sprinkle Capsules July 2003

Audience: Neurologists, Pediatricians, and other Healthcare professionals

Ortho-McNeil and FDA revised the WARNINGS and PRECAUTIONS sections of the prescribing information to provide updated information about oligohidrosis (decreased sweating) and hyperthermia, which have been reported in topiramate-treated patients. Oligohidrosis and hyperthermia may have potentially serious sequelae, which may be preventable by prompt recognition of symptoms and appropriate treatment.

[July 9, 2003 - Letter - Ortho-McNeil]