Topamax Receives More Serious FDA Safety Warning

In response to research done by the North American Antiepileptic Drug Pregnancy Registry, the FDA has moved Topamax from category C to D which is the second highest warning rating. The FDA move comes in light of data that suggests pregnancies exposed in utero to the drug Topamax have a significantly increased risk of being born with birth defects such as a cleft palate or cleft lip.
The new FDA category means that Topamax has a significant potential for causing injury or harm to an unborn child. The Topamax related injuries are severe in that they can cause pain and are permanent.
Topamax, manufactured by a subsidiary of Johnson & Johnson, is an anti-seizure drug that may be associated with an increased risk of birth injuries when compared to other anti-seizure drugs.