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New York Topamax Attorneys
Topamax Birth Defect Risks
Topamax (topiramate) is a medication that has been approved by the FDA to treat patients who have epilepsy and have certain kinds of seizures. There are over 40 different forms of epilepsy, and treatment for the condition varies. Between January 2007 and December 2010, over 32 million prescriptions for topiramate were dispensed and over 4 million patients in the U.S. filled prescriptions for the drug during that time.
FDA Topamax Warning: Link Between Topamax and Oral Birth Defects
In March 2011, the U.S. Food and Drug Administration (FDA) received new data analysis from the North American Antiepileptic Drug (NAAED) Pregnancy Registry that showed there was an increased risk of the birth defect oral clefts (cleft palate and/or cleft lip) occurring in infants whose mothers took Topamax during the first trimester of their pregnancy. Infants who were exposed to Topamax had an occurrence rate of oral clefts of 1.4 percent, in comparison to an occurrence rate of 0.38 – 0.55 percent in infants who were exposed to other drugs used to treat epilepsy. Infants born to mothers who did not have epilepsy and were not taking Topamax or another antiepileptic drug had an occurrence rate of just 0.07 percent. In a pregnancy register in the United Kingdom, similar connections were noted.
Based upon the new data, the labels for Topamax and generic topiramate will change to reflect a stronger warning. Additionally, the pregnancy category of the drug will be changed to Pregnancy Category D, which indicates there is evidence based upon human data that the drug poses a risk to human fetuses. However, in certain situations the benefits of the drug may outweigh the risks in pregnant women. Previously, the FDA categorized Topamax as Pregnancy Category C due to the lack of human data.
It is important for women who are pregnant and taking Topamax or are taking the drug and believe they may be pregnant to consult with their doctor before ceasing their dosage.
Topamax Lawyer in New York
If you have taken Topamax or are taking the antiepileptic drug, you likely have many questions. If your infant was born with an oral cleft, contact the New York product liability attorneys and Topamax lawyers at Wingate, Russotti, Shapiro & Halperin, LLP. We can help you determine whether your claim is valid. You may be able to receive compensation for medical expenses, pain and suffering, and more. Call 212-222-4336 today.
