• 04
  • March
    2011

The FDA announced recently that Topamax (topiramate) an antiepileptic/ migraine medication, is associated with up to a 20x increase in the risk of having a baby born with a cleft lip or palate.

The alarming data came from the North American Antiepileptic Drug Pregnancy Registry. According to Russell Katz, director of the FDA's division of neuropharmacological drug products, "health care professionals should carefully consider the benefits and risks of Topamax when prescribing to women of child bearing years ... alternative medications that have lower risks of birth defects should be considered."

The FDA also announced that it was immediately changing the pregnancy category warning for Topamax from a "C" to a "D." This alerts doctors and patients that a well-conducted study has shown evidence of birth defects in humans.