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U.S. Department of Health and Human Services

Safety

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Topamax (topiramate) Sep 2001

Audience: Neurologists, Ophthalmologists, and other Healthcare professionals

FDA and Ortho-McNeil have strengthened the WARNINGS and PRECAUTIONS sections in the label of Topamax Tablets and Sprinkle Capsules, indicated as adjunctive therapy for adults and pediatric patients ages 2-16 years with seizure disorders. Cases of secondary angle closure glaucoma characterized by ocular pain, accute myopia, and increased intraocular pressure were reported in pediatric and adult populations. The primary treatment is discontinuation of Topamax. If left untreated, serious sequelae, including permanent vision loss, may occur. Patients taking Topamax should be told to seek immediate medical attention if they experience blurred vision or periorbital pain.

[Sept 26, 2001 - Letter - Ortho-McNeil] 
[Oct 1, 2001 - Full revised label - Ortho-McNeil]