FDA Warns of Oral Cleft Birth Defects While on Topamax
March 21, 2011
On March 4, 2011, the Food and Drug Administration issued a warning that Topamax, also known as topiramate, increased the risk of birth defects such as cleft lip and cleft palate in children born to women who took the drug while pregnant. Topamax is prescribed to treat certain kinds of seizures in patients with epilepsy. It is also prescribed to help prevent migraine headaches. Seeger Weiss is currently investigating the connection between Topamax and birth defects.
The birth defects cleft lip and cleft palate occur when parts of the lip or palate (the roof of the mouth) do not fully meet in the first trimester of pregnancy. Many women do not know they are pregnant until the second trimester, and as a result, mothers cannot take the precautions necessary to prevent oral clefts in the first few months of their pregnancy. The severity of oral clefts range from a small notch in the lip to a gap that can continue into the palate and nose. The more severe cases of cleft palate can lead to problems with eating, talking, and to ear infections. Cleft lip and cleft palate are treated by a surgery that closes the space between lip, the roof of the mouth, and nose. Most children do well after the surgery.
The FDA cited statistics from the North American Antiepileptic Drug (AED) Pregnancy Registry in their warning. The data indicates an increased risk of oral clefts in babies exposed to Topamax (topiramate) during the first trimester of pregnancy. 1.4% of children whose mothers' took Topamax suffered from oral clefts, compared with 0.38– 0.55% of children whose mothers' took other anti-epileptic drugs. Only 0.07% of children whose mothers do not have epilepsy and are not taking anti-epileptic drugs suffer from left lips or cleft palates.
Seeger Weiss LLP is investigating injury claims associated with Topamax. If you or someone you know has taken Topamax while pregnant, and had children suffering from birth defects like cleft lip and cleft palate, contact us today. An experienced attorney with Seeger Weiss LLP will assist you in evaluating your claim. Attorney consultations incur no obligation on your part and all initial consultations are free of charge. Seeger Weiss LLP has office locations in New York, New Jersey, Philadelphia, Oklahoma and California.
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