Topamax
Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. It was originally produced by Ortho-McNeil Neurologics and Noramco, Inc., both divisions of Johnson & Johnson. It was discovered in 1979 by Bruce E. Maryanoff and Joseph F. Gardocki during their research work at McNeil Pharmaceutic. Generic versions are available in Canada and were FDA approved in September 2006.
Mylan Pharmaceuticals was recently granted final approval for generic topiramate 25, 100, and 200 mg tablets and sprinkle capsules by the FDA for sale in the US. 50 mg tablets were granted tentative approval. The last patent for topiramate in the U.S. was for pediatric use; this patent expired on February 28, 2009.[On May 21, 2010, Ortho-McNeil plead guilty and was fined US$6.14 million by the FDA for promoting Topamax to treat psychiatric disorders, without applying for any approval and there was no data from any well-controlled clinical trial to demonstrate that Topamax was safe and effective to treat any psychiatric conditions.
The US FDA Research issued an FDA Warning on March 4, 2011 citing the possibility of serious side effect birth defects linked Topamax use by pregnant women, including the increased risk of congenital birth defects such as cleft palate and cleft lip:
FDA: Risk of Oral Birth Defects in Children Born to Mothers Taking Topiramate (Topamax)
New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration said today.
Although no official Topamax FDA Recall has currently been issued by the FDA, the link between Topamax (Generic: topiramate) and the potential for congenital cranio-facial and oral cleft birth defects has many medical professionals concerned that pregnant women should not be prescribed the medication.
Women who are taking anti-seizure medications, including Topamax (Generic: topiramate) — and are pregnant or thinking about becoming pregnant should speak with their doctor about the risks associated with taking Topamax or any other anti-seizure medications while pregnant
At O’Hanlon, McCollom & Demerath,their attorneys understand that your child’s injuries may not be your fault – instead, possibly a dangerous side effect of Topamax. Our expertise and experience, combined with their highly trained staff, will make them uniquely well-equipped to handle even the most complex products liability claim as far as the Topamax lawsuit is concerned.
O’Hanlon, McCollom & Demerath – Personal Injury Lawyers – 808 West Avenue, Austin, TX. 78701 – 512-494-9949
