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Topamax
Birth Defect/Injury | Cleft Lip | Cleft Palate
Topiramate is an anticonvulsant medication approved for use alone or with other medications to treat patients with epilepsy who have certain types of seizures. Topiramate is also approved for use to prevent migraine headaches but not to relieve the pain of migraine headaches when they occur.
According to the FDA, new data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry that show an increased risk of oral clefts (cleft lip and/or palate) in infants who are exposed to topiramate during the first trimester of pregnancy. Oral clefts are defects in the formation of the upper lip and/or roof of the mouth.
Oral clefts can affect the way a child's face looks, and can lead to problems with eating, talking, and/or ear infections. Most infants born with oral clefts undergo surgery to close the lip and/or palate during their first year of life. Oral clefts happen early in pregnancy, before many women even know they are pregnant. Oral clefts also occur in infants whose mothers did not take topiramate or other medications during pregnancy, but they occur less often.
From January 2007 through December 2010, approximately 32.3 million topiramate prescriptions were dispensed and approximately 4.3 million patients filled topiramate prescriptions from the outpatient retail pharmacies in the U.S.
After considering the recent NAAED Pregnancy Registry data, the FDA will be reclassifying topiramate as a pregnancy category D drug. In essence, a label change will take place for Topomax (topiramate). In addition, the FDA website states that Topomax (topiramate) has also been used off-label (for unapproved uses) for other conditions, some of which may not be considered serious.
If your child has a cleft lip and/or cleft palate, or any other birth defects listed above, and you took Topamax or generic topiramate during pregnancy, you may be entitled to compensation. Contact a pharmaceutical lawyer from Gooch Law Firm by e-mail, or by calling Joel Gooch at 1-800-672-4916.
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