Topiramate is used alone or with other medications to treat certain types of seizures in people who have epilepsy. Topiramate is also used with other medications to control seizures in people who have Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delays). Topiramate is used to treat patients who continue to have seizures even when they take other anti-seizure medications. Topiramate is also used to prevent migraine headaches, but not to relieve the pain of migraine headaches when they occur. Topiramate is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.
The FDA Warning of 2011
In March 2011, the FDA issued a warning that Topamax side effects may increase the risk of oral cleft birth defects, such as cleft lip and cleft palate, among babies born to mothers who took the drug during the first trimester of pregnancy. As a result of inadequate warnings previously provided, many women were not aware they may be exposing their baby to a potential risk of Topamax birth defects.
The FDA has urged doctors to avoid giving Topamax to pregnant women or women who are of child-bearing age and at a high risk of pregnancy. Alternative epilepsy drugs may not carry the same risk for the unborn child.
In July 2008, a small study published in the medical journal Neurology identified a potential link between the use of Topamax during pregnancy to an increased risk of serious birth defects. Children born to women who used Topamax during pregnancy were found to develop a cleft lip or palate at a rate 11 times hirer than would be expected in the general population. The study also indicated that children exposed to Topamax developed genital defects at a rate 14 times higher than would be expected.
The FDA required new warnings in 2011 after data from the North American Antiepileptic Drug Pregnancy Registry found that children born to mothers who took Topamax during the first trimester of pregnancy experienced an oral cleft about 1.4% of the time, compared to a prevalence rate of between 0.33% and 0.55% associated with other epilepsy drugs.
Do I have a Topamax Lawsuit?
The attorneys at Slater Slater Schulman LLP are dedicated to the representation of plaintiffs in Topamax lawsuits. Our firm is handling litigation related to these injuries nationwide.
If you or someone you love has taken Topamax, you should contact Slater Slater Schulman LLP for a free consultation by filling out the form on this page or by calling us at (800) 251-6990.