(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 $81 million settlement. The agreement was reached in order to settle allegations that the companies had illegally promoted the drug for “unapproved” or “off-label” uses. The Department stated that this “unlawful marketing undermines the FDA’s important role in deciding which drugs are safe and effective for consumers and costs the taxpayers billions of dollars each year" (iii). Also, Johnson & Johnson acknowledged in its most recent annual report that it was facing at least 75 birth defect lawsuits related to this drug (iv).
The new informational graphic provides information on the drug’s side effects as well as a timeline. Visit the webpage and view the Topamax infographic. d’Oliveira & Associates is currently working with some of the more experienced Topamax lawyers in the country who are handling these birth defect lawsuits. Contact the law firm to receive a free legal consultation and there is no fee unless you receive a settlement or award. Call toll-free at 1-800-922-6878 or fill out a contact form on their website in confidence.
(i) Drug Safety Communication, March 4, 2011.
(ii) Safety Review: Topirmate Use During Pregnancy, June 1, 2010.
(iii) U.S. Department of Justice Press Release, April 29, 2010.
(iv) Johnson & Johnson 2012 Annual Report