Women who use the epilepsy drug Topamax (topiramate) while they are pregnant are at an increased risk for delivering a baby with a cleft lip and/or cleft palate, according to a safety warning issued by the Food and Drug Administration (FDA).
Topamax is approved by the FDA for the treatment of partial onset seizures and migraine headaches. It is also prescribed for uses not approved by the FDA. It was previously classified as a Pregnancy Category C drug, meaning that data in animal studies shows a potential for birth defects but that there have been no adequate studies done in human populations to determine the risks.
However, recent data from the North American Antiepileptic Drug Pregnancy Registry showed that women who used Topamax during the first trimester of pregnancy were 21 times more likely to give birth to a baby with a cleft lip and/or cleft palate.
In March 2011, the FDA notified doctors and patients that Topamax and its generic equivalents were being reclassified as Pregnancy Category D drugs. Category D drugs are those in which there is positive evidence of birth defects based on human data, however there may be certain situations where the drug may be acceptable in pregnant women despite the risks.
The agency advised that the benefits and risks of the drug be carefully weighed in women of childbearing age, particularly for conditions not usually associated with permanent injury or death. Alternate medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients.
If the decision is made to use Topamax in women of childbearing age, effective birth control should be used. Oral clefts occur in the first trimester of pregnancy before many women know they are pregnant.