FDA Questions Topamax Oral Cleft Birth Defects

FDA Questions Topamax Oral Cleft Birth Defects (February 5, 2011) U.S. Food and Drug Administration (FDA) asked Vivus to assess potential risks of oral cleft birth defects associated with taking an anticonvulsant drug, Topamax, during pregnancy. In a report posted over the internet on January 21 of this year, the federal regulators asked the pharmaceutical company to consider the feasibility of analyzing healthcare databases to determine how often pregnant mothers treated with Topamax had children with birth defects. In a study published in the medical journal Neurology in 2008, researchers suggested that using Topamax as a medication for migraines is not appropriate for pregnant women. A migraine is a devastating condition characterized by moderate to severe headaches and nausea, which is three times more common in women than men. According to the study which includes 203 pregnant women who took the anticonvulsant drug either alone or in combination with other anti-epilepsy drugs, four babies were born with cleft palates or lips, while four male babies had genital birth defects known as hypospadias. Birth defects are abnormalities in body structure, function and metabolism present at birth. The most common birth defects include cleft lip or palate, Down syndrome, congenital heart disease, spina bifida and cystic fibrosis. In the United States, one out of every 700 children born has congenital deformities which can only be treated with surgery. However, in most cases, these kinds of congenital defects were caused by medications taken during the first three months of pregnancy, causing problems in the development of the fetus in the mother’s womb. Recent studies showed the use of Topamax during pregnancy can increase the risk of congenital defects eleven times higher than expected in the general population. The FDA request came after the federal regulators found the active ingredient topiramate combined with phentermine in the proposed new weight loss drug Qnexa. In addition, review of the Topamax birth defects came after the FDA looked at two reports on oral clefts recorded in the United Kingdom Epilepsy and Pregnancy Register and four reports from the North American ARV Pregnancy Register.

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