Topamax Birth Defects
Topamax and Risk for Development of Cleft Lip and/or Palate in Newborns
On March 4, 2011, the FDA notified healthcare professionals and patients of an increase risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy. Because of new human data that show an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks. This warning comes almost three years after an article, published in The Neurology Journal, raised the issue of the safety of Topamax during pregnancy.
On March 7, 2011, the University of Utah, Department of Pharmacy, issued an alert regarding the use of Topamax (Topiramate) by pregnant women. The University of Utah alert is based on information from the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Cleft lip or palate has occurred in 1.4% of infants exposed to topiramate in the first trimester of pregnancy. The frequency of oral cleft was 0.38%-0.55% in infants whose mothers were exposed to other antiepileptic medications and 0.07% in infants whose mothers did not have epilepsy and were not on antiepileptic medications. Women who have taken or are taking topiramate during pregnancy may call the NAAED Pregnancy Registry at 1-888-233-2334.
The FDA warning also comes after the April, 2010 settlement where Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc., both subsidiaries of Johnson & Johnson, have agreed to pay more than $81 million to resolve criminal and civil liability arising from the illegal promotion of the epilepsy drug Topamax. See Topamax\Justice Department.htm
Topamax is an anti-seizure medication and it can also be used to treat migraine headaches.
James Esparza has decades of experience in representing individuals and families who have been seriously injured by defective prescription medicine. Our law firm represents clients throughout the United States.
If you or a loved one has given birth to a child with a congenital birth defect after taking Topamax while pregnant call Us Now at 1-800-745-4050 for a confidential consultation or complete our Contact Us/Do I Have A Case feature on our web site. We would like to help you.
Helpful links
http://www.neurology.org/content/71/4/272.abstract
