The FDA has released new data showing that topiramate increases the risk for cleft lip and cleft palate birth defects when taken during pregnancy. The FDA has ordered the manufacturers of topiramate to include a stronger warning in its labeling.
Data shows that 1.4 percent of infants exposed to topiramate during early pregnancy were born with oral clefts. This is about 3 times the rate of oral clefts in infants exposed to other types of antiepileptic medications. It is 20 times the rate of oral clefts in infants not exposed to any antiepileptic drugs.
Cleft lip and cleft palate occur when parts of the lip or palate do not completely fuse together during early pregnancy. Surgery is the only way of correcting cleft lip or cleft palate. Many women do not realize they are pregnant during early pregnancy, increasing the risk of exposure.
Topiramate is an anti-seizure drug approved to treat epilepsy and to prevent migraines. It is marketed under the following names:
- Topamax Sprinkle
Between January 2007 and December 2010, about 32.3 million topiramate prescriptions were dispensed and about 4.3 million patients filled topiramate prescriptions at retail pharmacies in the U.S. Ortho-McNeil Pharmaceutical, which makes Topamax, pleaded guilty in 2010 to illegally promoting topiramate between 2001 and 2003 for off-label use. Although topiramate has only been approved for the treatment of epilepsy and migraines, it has been prescribed for many off-label conditions, including:
- Bi-polar disorder
- Obsessive-compulsive disorder
- Cluster headaches
- Bulimia nervosa
- Cocaine dependence
At Brown & Crouppen our experienced team of Topamax and defective drug lawyers provide tough, aggressive representation for Topamax victims and their families. We’ll find answers, hold negligent companies responsible and may be able to help you get the compensation you deserve. Call us toll-free at 1-800-536-4357 for your free legal consultation or save time with our online contact form.
Contact the Attorneys of Brown & Crouppen
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