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On March 4, 2011, the FDA required the manufacturers of Topamax to significantly strengthen warnings for the drug because of increasing data linking the product to certain types of birth defects including Cleft Lip, Cleft Palate, and genital malformations including Hypospadias. The FDA has increased the warning class of Topamax from Pregnancy Class C to Class D. A Pregnancy Category D occurs when there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans.
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