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Topamax is a drug used to treat seizures associated with epilepsy. It has also received FDA approval to treat migraines, and in recent years has become one of the most widely-prescribed migraine medications in the country. The drug is manufactured by Ortho-McNeil Neurologics, a subsidiary of Johnson & Johnson. It is also sold under its generic name, topiramate.

New research has indicated that Topamax increases the risk of birth defects in babies born to women using this drug while pregnant. In particular, babies face an increased risk of oral clefts such as cleft lip and cleft palate. Unfortunately, due to inadequate warnings, many women have unknowingly been exposing their babies to these risks.

What are Oral Clefts?

Oral clefts are birth defects occurring when parts of the lip or palate do not properly fuse together during the first trimester of pregnancy. Oral clefts can range in severity from a small notch in the lip to a groove that runs into the roof of the mouth and nose.

Babies born with oral clefts often have difficulty eating and talking, and they are prone to getting frequent ear infections. Surgery is often required to correct the condition.

FDA Increases Warnings on Topamax Label

In March 2011, the Food and Drug Administration (FDA) issued a warning regarding the association between Topamax and the increased likelihood of these birth defects. Doctors have been advised to avoid prescribing the drug to women who are pregnant or plan on becoming pregnant in the near future. Instead, alternative epilepsy drugs are recommended for these women.

The FDA has also placed a stronger warning on the drug’s label. It has changed the pregnancy category to Pregnancy Category D, which indicates evidence of risk to the unborn baby; however, the potential benefits of the drug may outweigh the risks in some circumstances.

The change in the Topamax label was prompted by recent data demonstrating these increased risks of birth defects. Infants exposed to Topamax in the womb experienced a 1.4% prevalence of oral clefts, while children born to women taking other epilepsy drugs experienced a .38-.55% prevalence rate. Children born to mothers who do not take any kind of epilepsy drugs experience a .07% prevalence rate of oral clefts.

Jacoby & Meyers Can Help

If your baby was born with an oral cleft due to your consumption of Topamax during pregnancy, you may be entitled to receive compensation for your child’s damages. The pharmaceutical injury lawyers at Jacoby & Meyers have years of experience handling these challenging claims. We are a large national law firm with the vast resources necessary to battle the high-powered legal teams assembled by pharmaceutical companies. We will fight aggressively to ensure that you receive the compensation you deserve.

Please contact our experienced pharmaceutical injury lawyers today to schedule your free initial consultation. Jacoby & Meyers has offices nationwide.