The news source reports that as a result of the new information, the FDA has decided to strengthen its warnings about the medication and similar generic drugs.
The decision by the FDA represents just the latest reputation setback to Johnson & Johnson, which owns the manufacturer of Topamax, Ortho-McNeil Pharmaceutical, according to the news provider. Johnson & Johnson has issued a number of medication and medical device recalls in recent months.
According to the FDA, data from the North American Anti-Epileptic Drug Pregnancy Registry demonstrated a higher risk of oral clefts in babies who were exposed to topiramate, the main ingredient in Topamax, during the first trimester of pregnancy.
In addition to the birth defects, other Topamax side effects can potentially include blurred vision, nausea and chest pain, according to the National Center for Biotechnology Information.