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Injury Law Firm Releases New Informational Graphic on the Alleged Birth Defect Risks of Dangers of Topamax
Date:7/29/2013

(PRWEB) July 29, 2013

Topamax (topiramate) is a drug used to treat epilepsy and prevent migraines. It has also been used for off-label weight loss for many years and recently the FDA approved a combination of topiramate and phentermine for weight loss. In 1996, the FDA approved Topamax for manufacture and marketing by McNeil Pharmaceuticals and Janssen Pharmaceuticals, which are both owned by Johnson & Johnson. Since the drug’s introduction to the market, it has earned billions of dollars in sales. In fact, the FDA has reported that between January 2007 and December 2010 approximately 32.3 million prescriptions were filled by 4.3 million people (i).

In March 2011, the FDA issued a Drug Safety Communication about a potential link between Topamax use in pregnancy and birth defects. It stated 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.” The FDA also added the drug to Pregnancy Category D meaning “there is positive evidence of human fetal risk based on human data.” It based this change on data from the North American Antiepileptic Drug Pregnancy Registry and a previous analysis of adverse events (i). According to a June 2010 Safety Review of the drug, the FDA had received 67 reports of birth defects including 21 facial defects (11 reports of cleft lip/palate), 19 malformations, and 15 cardiovascular defects (ii). Women who have used this drug and given birth to a child with a birth defect should talk to a drug lawyer about filing a lawsuit.

Recent reports show that Johnson & Johnson had to pay a multi-million dollar settlement and now faces at least 75 birth defect lawsuits due to the promotion and selling of Topamax. In April 2010, the U.S. Department of Justice announced that Johnson & Johnson affiliates, Janssen and McNeil, agreed to pay an
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