Why Was There An FDA Warning Of Topamax?

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.

The information on this page is meant to provide a general overview of the law. The laws in your state and/or city may deviate significantly from those described here. If you have specific questions related to your situation you should speak with a local attorney.

Additional Topamax Articles

Search LawInfo's Topamax Resources