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Generic: Topiramate
Approved to treat: Seizures and migraines
Drug category: Anticonvulsant
Year approved: 1996
Manufacturer: Johnson & Johnson

Babies who are prenatally (before birth) exposed to Topamax have an increased risk of developing birth defects, including:

  • Cleft Palate – 11 times increased risk
  • Cleft Lip – 11 times increased risk
  • Genital defects – 14 times increased risk

Multiple Studies Find Link Between Topiramate Use and Birth Defects

Cleft lip and cleft palate, which can often occur together, are some of the common common birth defects that have been linked to Topamax. If this occurs, the lips or palate don’t fuse together properly leaving an opening or a gap in the face.

In March 2011, the U.S. Food and Drug Administration (FDA) released a warning regarding the increased risk of birth defects for pregnant women who take Topamax. The FDA referenced a report released by the North American Antiepileptic Drug Pregnancy Registry, which stated that Topamax increases the risk of oral cleft birth defect by four times compared to women taking other antiepileptic drugs. In some cases, the study showed that Topamax users are 20 times more likely to give birth to children with oral clefts. The FDA moved the drug to a Pregnancy Category D, which means that there is a significant possibility of harm to the unborn babies.

A research study performed by the Royal Group of Hospitals in Belfast, Northern Ireland, studied 203 women who became pregnant while talking topiramate. Of the 203 pregnancies, 18 ended in miscarriages, two in stillbirths and five in induced abortions. Of the 178 babies that were born, 16 had major birth defects. Four of the babies had cleft palates or lips, a rare 11 times the normal rate of one in 500 expected among women not taking epilepsy drugs. Four male babies had genital birth defects, which is 14 times the normal rate of one in 300.

While the risk varies for each defect, one thing is clear: women should be warned of these dangerous and potentially fatal side effects before becoming pregnant. Unfortunately, the manufacturers of SSRI anti-depressants are not currently required to warn users of these increased risks and, as a terrible result, babies continue to be ha

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