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Topamax risks reiterated near drug’s FDA anniversary

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In a year-end affirmation of previous science, a study published in the November 2012 edition of the American Journal of Obstetrics and Gynecology concluded, “First-trimester use of topiramate may be associated” with “cleft lip with or without cleft palate in the offspring.”

The conclusion about the heightened risk is based on data from the 12-year Slone Epidemiology Center Birth Defects Study and from the decade-long National Birth Defects Prevention Study. In those studies, patients took only topiramate for the treatment of their conditions.

The drug is manufactured and marketed by Janssen as Topamax, “an antiepileptic agent” for adult and pediatric patients that is also used to prevent “migraine headache” in adults, according to the updated prescription information that the U.S. Food and Drug Administration OKd in October 2012.

The FDA originally approved Topamax on Christmas Eve 1996, according to the administration’s correspondence bearing that effective date.

According to the FDA, “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.” from 2007 through 2010.

The robust sales took place months before new information was available and released.

The FDA in March 2011 issued a safety alert in regard to “new data that show that there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with topiramate (Topamax and generic products) during pregnancy.”

Topamax lawsuits have been filed on behalf of victims who have exercised their rights to recover damages, including medical expenses.

Topamax-related birth defects can range drastically in severity. In some cases, the defect may be a small notch in the lip, and in more severe cases it may be a groove that runs from the nose into the roof of the mouth. These more severe oral defects can cause problems when eating, drinking and speaking. In many cases, surgery is required to close the lip and palate.

The personal injury attorneys at Reich & Binstock represent plaintiffs in Topamax lawsuits who would have been able to avoid the increased risks of birth defects associated with Topamax had they been properly informed of the unreasonable danger. For a free consultation, one may contact one of the experienced Topamax attorneys at Reich & Binstock toll-free at 1-866-LAW-2400.