Topamax and Birth Defects

by Terry Bryant

Topamax and Birth Defects

The Food and Drug Administration (FDA) approved the drug Topamax (topiramate) in 1996 as an anti-convulsant.  While it is used to treat epilepsy, Topamax is more commonly prescribed to prevent migraine headaches. Topamax is also prescribed to treat obesity, alcoholism, and bipolar disorder.

After 15 years on the market and becoming one of Janssen Pharmaceuticals top sellers, earning the manufacturer millions of dollars in sales, the FDA issued a warning of the increased risk of cleft lip or cleft palate associated with the drug. In that warning, the FDA cited research that found women who took Topamax in the first trimester of pregnancy were 16 times more likely to have babies born with oral cleft defects in comparison to other women included in the study.

An oral cleft is a birth defect where there is an opening in the lip and/or roof of the mouth, also called the palate that is caused by incomplete development during early fetal formation. Such defect may range from a narrow gap in the lip as seen in a cleft lip, to a gap that spans the entire roof of the mouth and nose as seen in a cleft palate. Both form of cleft is considered a cosmetic defect, and corrective surgery may be sought to treat an affected child. However, if a child’s cleft remains uncorrected, he or she may face problems with speech, an increase in the likelihood of ear infections, and even issues associated with his or her social life and self-image.

Oral cleft defects occur early on in a child’s development. In some cases, the defect may develop before a woman is aware of being pregnant, which can make it difficult for her to protect her child. In 2011, the FDA issued the warning of the increased risk of cleft lip or cleft palate associated with Topamax, and officials urged doctors to advise women of childbearing age of that risk. The FDA also classified Topamax as a Pregnancy Category D drug, meaning that there is positive evidence of fetal risk based on human data, and asked that the drug’s label be updated to reflect a stronger classification and warning.

On October 30th. a Pennsylvania jury found that Janssen Pharmaceuticals Inc. negligently failed to warn the risk of birth defects from the epilepsy drug Topamax. The negligence was a major contributor in causing a cleft lip/cleft palate in the son of a lead plaintiff, awarding the injured minor $4 million in damages. Janssen also failed to warn medical physicians about the debilitating birth defects. There are about currently 134 pending cases in Philadelphia over the epilepsy drug.

If taking a medication as it was prescribed harms a patient, the firm suggests discussing your case with a qualified attorney immediately. Doing so will help ensure any rights to compensation the patient may have are protected.