Medical Marketing and Media - FDA posts labeling change for Topamax
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The FDA issued a September 26 MedWatch notice that Ortho-McNeil has strengthened the Warning and Precaution sections of the labeling for its Topamax (topiramate) tablets and Sprinkle capsules, which are indicated as an adjunctive therapy for adults and children ages 2-16 with seizure disorder. A “Dear Healthcare Professional” letter issued by the company warned that the drug has been identified as causing an ocular syndrome in patients characterized by acute myopia and secondary angle closure glaucoma. The letter said that symptoms typically occur within the first month of therapy.
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