Topamax (topiramate) Tablets/Sprinkle Capsules - Jul 10, 2003
Audience: Neurologists, Pediatricians, and other Healthcare professionalsOrtho-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] PDF Format
[June, 2003 Revised label - Ortho-McNeil] PDF Format