Only one month after Johnson & Johnson was required to put a black box warning on Regranex and a week after the U.S. Food and Drug Administration rejected a black box warning on epilepsy drugs, research has found that J&J's Topamax may increase the risk of birth defects.
The study, a small one of 203 patients, found a 14-fold increase in the risk of birth defects in patients taking the epilepsy drug Topamax. The risk was potentially even higher in patients that took Topamax with valproate (Depakote) or other epilepsy medications.
Due to the small size of the study, experts have stressed that more research is needed to confirm the possible birth defect link. Experts also stated that pregnant women who suffer from epilepsy should not stop taking there drug as the seizures without the medication can have an even greater damaging effect on the fetus. However patients taking the medication for the purpose of migraine relief and who are pregnant or contemplate getting pregnant are prompted to talk to the health care provider about a suitable alternative.