Topamax Birth Defect Risk

Important Update: The U.S. Food and Drug Administration (FDA) notified patients and healthcare providers about a link between Topamax and birth defects on March 4, 2011. According to the agency, babies whose mother’s are treated with Topamax (topiramate) during their pregnancy have an increased risk of developing cleft lip or cleft palate.

The FDA says the drug’s label will be updated to include information about the birth defect risk. In addition, Topamax has been placed in Pregnancy Category D. Defective drugs placed in this category have been linked to birth defects. In some cases, the benefits of these drugs may outweigh the potential birth defect risk.

Patients should consult their doctors if they become pregnant while taking Topamax.

Topamax (topiramate) is an anticonvulsant medication used to treat patients with epilepsy and other types of seizures. The drug is manufactured by Johnson & Johnson. Generic versions are available.

Topamax Cleft Lip Birth Defect

According to data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry, Topamax (topiramate) increases the risk of cleft lip or cleft palate in infants whose mother’s take the drug while pregnant. The lip or palate does not fuse in children with cleft lip or cleft palate. The problem occurs during the first trimester.

The FDA will add a warning to the packaging label to warn patients of the potential risk. The agency has also asked that healthcare providers warn patients that are of child-bearing age about the potential dangers. If a woman becomes pregnant while being treated with Topamax (topiramate), it is important that she consult her doctor before stopping use of the medication.

Johnson & Johnson has agreed to work with the FDA to update the drug’s packaging label. The drug used to belong to Pregnancy Category C before data confirmed an increased risk of birth defects.

Topamax Birth Defect Lawsuits

If you were treated with Topamax (topiramate) during your pregnancy and gave birth to a child with a cleft lip or cleft palate, you might be eligible for financial compensation. Contact a Topamax birth defect lawyer at AWKO law today at (844) 794-7402 to schedule an evaluation of your case.

More Topamax News From Our Blog