Pregnant women taking Topomax have an increased risk of bearing children with birth defects such as a cleft lip or palate, the Food and Drug Administration (FDA) announced today. The agency is now changing the drug’s label warning and pregnancy classification to inform women about the drug’s defects.
Topomax – known as topiramate in its generic form – is prescribed to treat epileptic seizures and prevent migraine headaches. It is also used on an off-label basis to treat weight loss, alcohol dependence and psychiatric illnesses such as bipolar disorder.
Topomax is manufactured by Ortho-McNeil-Janssen, which has headquarters in Raritan, New Jersey.
New data from the North American Antiepileptic Drug Pregnancy Registry show infants exposed to topiramate as a single therapy in the first trimester had a 1.4 percent prevalence of personal injury and oral cleft birth defects.
This is compared to .38 – .55 percent for other antiepileptic drugs. The oral cleft birth defect rate was .07 percent for infants born to mothers without epilespy and who were not treated with other antiepileptic drugs.
The FDA has re-classified Topomax from a Pregnancy Category C to Pregnancy Category D drug, indicating there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks.
The FDA is advising doctors to avoid prescribing the defective drug to women of childbearing age because oral clefts occur in the first trimester before many women know they are pregnant. Doctors are advised to seek alternative medications or if that’s not possible, to recommend proper use of birth control.