Infants exposed to the anti-seizure and migraine prevention drug topiramate in utero have a higher risk of developing cleft lips and palates, according to the U.S. Food and Drug Administration.
The FDA is strengthening warnings for the drug, which Johnson & Johnson markets under the brand name Topamax. It is also available as a generic.
The Wall Street Journal reports the FDA Center for Drug Evaluation and Research’s Division of Neurology Products is urging health care professionals to warn patients of childbearing age about topiramate’s risks and to consider alternative medications with a lower risk of birth defects.
Data shows that 1.4% of infants exposed to the topiramate suffered the birth defect, compared with 0.38% to 0.55% of infants exposed to alternative anti-epileptic drugs. Infants born to mothers without any such treatment are born with cleft lips or palates at a rate of 0.7%, according to The Wall Street Journal.
Topiramate is approved to treat certain types of seizures and epilepsy, and it is a component of the weight-loss drug Qnexa, which is under development by Vivus.