March 07, 2011

Mom's Migraine Medicine: FDA says Topamax may hurt unborn babies

The Food and Drug Administration (FDA) has new data showing that the migraine and anti-seizure drug Topamax (Topiramate) may increase the risk of birth defects in babies born to women who took the medication while pregnant. This data was received from the North American Antiepileptic Drug Pregnancy Registry.

The FDA's data links women who took Topamax while pregnant to babies born with cleft lips or palate deformities, as well as other fetal and skeletal malformations that include but are not limited to genitalia abnormalities. FDA officials are advising doctors to warn their female patients, especially expecting mothers, of the potential risks associated with taking this medication during pregnancy.   

A cleft lip or cleft palate occurs when the mouth fails to fully form, causing a "split lip" or a hole in the roof of the mouth. These deformities may cause developmental issues and make it difficult for newborns to receive adequate nutrition. Some of these and other conditions associated with Topamax use can be fixed through surgery.

Read more about potential Topamax side effects in the FDA's press announcement.

Learn more about how Topamax lawyers fight on behalf of individuals suffering from potentially dangerous drugs and fight to hold accountable those responsible for negligent medical care, corporate wrongdoing, and inadequate warning, research and testing.