FDA Warns That Topamax May Cause Oral Cleft Birth Defects

On March 4, 2011, the Food and Drug Administration issued a warning that the drug Topamax, the brand name for topiramate, increases the risk of birth defects such as cleft lip and cleft palate in children born to women who take 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.

Defects Form in the First Trimester, Before Many Mothers Can Prevent Exposure
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. Oral clefts range from a small notch in the lip to a gap extending into the palate and nose. 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.

Children Exposed to Topamax Experience an Increase of Oral Clefts

In its warning, the FDA cited statistics from the North American Antiepileptic Drug (AED) Pregnancy Registry that show an increased risk of oral clefts in babies exposed to Topamax 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.

If you or someone you love has taken Topamax while pregnant and given birth to a child with an oral cleft birth defect, you should contact the Plymale Law Firm for a free consultation by filling out the form on this page or by calling us at (877) 328-767­­0.

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