FDA Warns about Topamax Side Effects

Washington, DCThe US Food and Drug Administration (FDA) has issued a warning about a risk of Topamax side effects, which reportedly include an increased risk of Topamax birth defects. The FDA's warning concerns the link between use of Topamax and pregnancy, warning that babies exposed to Topamax prior to birth could be at an increased risk of birth defects around the mouth.

Topamax, known generically as topiramate, is an epilepsy drug, used for patients who have certain types of seizures. It is also approved to prevent migraine headaches but is not approved to relieve the pain of migraine headaches once they occur.

The FDA has warned that children exposed to topiramate prior to birth are at an increased risk of cleft lip and cleft palate. The conditions occur during the first trimester of pregnancy, meaning they may have already developed before the mother is even aware she is pregnant. As such, FDA warns that the risks of using Topamax and topiramate should be carefully weighed against the benefits for women of childbearing age.

The FDA's announcement came after a review of data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry, which found an increased risk of oral clefts in infants who were exposed to topiramate during the first trimester. Data from the study showed the prevalence of oral clefts in infants exposed to topiramate was 1.4 percent, compared with between 0.38 and 0.55 percent in infants exposed to other antiepileptic medications.

Data from the UK Epilepsy and Pregnancy Register showed a similar increased risk in infants who were exposed to topiramate prior to birth.

As a result of the data from the NAAED Pregnancy Registry, the FDA changed topiramate from a Pregnancy Category C drug to a Pregnancy Category D drug. Pregnancy Category D indicates that there is evidence of risk to a human fetus based on human data, but there are still potential benefits from the medication that may make that risk acceptable in certain situations.

Cleft palate and cleft lip can be treated with surgery. Most children with cleft lip or cleft palate do well following treatment, according to the FDA.

Women who are of childbearing age and are taking topiramate are urged to speak with their doctors about treatment options.