The FDA is strengthening warnings on the anti-seizure drug Topamax® because new data suggest an increased risk of birth defects when used by expecting mothers during pregnancy. The drug has also been enhanced to Pregnancy Category D, which means that conclusive evidence has linked Topamax to cleft lip, cleft palate and cranial malformations. Topamax is also sold under the generic name topiramate. Free Topamax Case Evaluation: If you or a loved one has given birth to a child with cleft lip, cleft palate, or any other physical deformity after taking Topamax, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
Topamax Birth Defects Update 7/19/12: A recently-published study, based on more than a decade’s worth of data, has confirmed prior research which identified a strong link between Ortho-McNeil’s controversial anti-convulsant Topamax (generic: topiramate) and oral cleft birth defects. This risk is greatest when expecting mothers take Topamax during their first trimester of pregnancy, a time when many women may still be unaware they are pregnant. Click here to learn more.
What’s the problem?
New data suggest that the anti-epileptic medication Topamax (topiramate) increases the risk for the congenital birth defects cleft lip and cleft palate in children born to mothers who use the medication during pregnancy. Cleft lip and cleft palate are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant. Data from the North American Antiepileptic Drug Pregnancy Registry showed the problem occurred in 1.4% of infants exposed to topiramate compared to a rate of 0.38% to 0.55% in newborns exposed to other antiepileptic drugs in utero. Children born to women without epilepsy had a prevalence of 0.07%. The FDA said the finding is supported by similar data from the United Kingdom Epilepsy and Pregnancy Register. In addition to being used to control epileptic seizures, Topamax has also been prescribed for preventing migraine headaches and appetite control. For those uses, the risk is much higher. According to the FDA, over 32 million prescriptions for Topamax were dispensed nationwide to 4.3 million patients between 2007 and 2010.
FDA Press Release on Topamax Birth Defects
If you’d like to learn more about Topamax and the risk of birth defects, please visit the FDA website to view the official press release
Do I have a Topamax Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Topamax lawsuits. We are handling individual litigation nationwide and currently accepting new cleft lip & cleft palate birth defect cases in all 50 states.