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Cleft Palate and Lip Birth Defects Linked to Topamax

Earlier this year, the United States Food and Drug Administration issued a warning about the connection between anticonvulsion drug Topamax and certain birth defects. The FDA noted that there is an increased risk for the development of cleft lip and/or cleft palate in infants born to women treated with the drug during pregnancy, according to recent research. Cleft lip and cleft palate range from a small notch in the lip to a groove that runs into the roof of the mouth and nose. Surgery is most often used to close the gap, and most children do well with treatment. Topamax is made by Ortho-McNeill Pharmaceutical, a division of Johnson & Johnson. In addition to convulsions, Topamax has also been approved for the treatment of epilepsy and migraine headaches.

No Adequate Human Studies During FDA Approval

The active ingredient in Topamax and its generic equivalents is topiramate. Topiramate was previously classified by the FDA as a Class C pregnancy drug, which means that potential fetal risks were suggested by animal research, but there were no adequate data from human studies at the time of FDA approval. In light of the latest research, topiramate has now been classified as a Class D pregnancy drug with positive evidence of human fetal risk. Despite this, the FDA believes that there may be potential benefits from the drug's use by pregnant women in some situations.

The FDA offered several suggestions about women of child-bearing age who take Topamax. Women who are taking the drug and not planning a pregnancy should use effective birth control. They should immediately advise their doctor if they become pregnant while taking the drug. Topiramate also passes into breast milk, so mothers should discuss the best way to feed their baby with health care professionals if they did take the drug while pregnant. If taking topiramate, a health care professional should be consulted before stopping the drug, even if the patient is pregnant. Serious health problems can result from stopping topiramate suddenly.

If you or a family member took Topomax or a generic equivalent containing topiramate while pregnant, you should consult with a defective drug attorney experienced in pharmaceutical law to protect your rights.