The Food and Drug Administration is warning that a popular drug for treating epilepsy and migraines comes with a substantial risk of birth defects, including cleft lips and cleft palates.

Our New York personal injury lawyers have written extensively about dangerous pharmaceuticals and the growing risk of birth defects. The Food and Drug Administration has come under fire repeatedly for failing to protect the public from dangerous pharmaceuticals or defective medical products.

Meanwhile, as we reported in June on our New York Injury Lawyer Blog, New York birth mothers face some of the highest risks in the nation.

Certainly it is incumbent upon your physician to advise you of the risks medications present and help you make informed choices about your welfare and the health and welfare of your unborn child. With this latest announcement, the FDA has moved Topamax from a Category C drug (meaning no human data available) to a Category D drug, which means there is an evidenced risk of fetal injury but use may still outweigh the risk in some cases.

The Antiepileptic Drug Pregnancy Registry found birth defects present in about 1 in 66 infants whose mothers had taken Topamax. That rate was 3 to 5 times higher than infants exposed to other antiepileptic drugs and about 20 times higher than the national average.

Topamax is manufactured by Johnson & Johnson and contains the drug topiramate, which is also available as a generic. The drug is used to prevent migraines and treat epilepsy. Evidence shows the drug may prevent an infant's lip or palate from properly fusing in the first trimester.

Johnson & Johnson is also dealing with a recall of its defective DePuy hip-replacement system, after officials in the U.K. reported a high failure rate and the presence of metal in the blood.

The Wall Street Journal reports Johnson & Johnson made $2.7 billion selling Topamax before losing patent protection in 2008; the company still made $538 million last year. It pleaded guilty last year to promoting the drug for unapproved uses and paid an $81.5 million fine.