Topamax Cleft Palate and Lip Trial Starts in Philadelphia

A Virginia woman wouldn’t have taken Topamax for more than six months to treat migraines had she known the risks to her unborn child, her lawyer told the jury in a trial that began on October 15 in the Philadelphia Court of Common Pleas.

The woman filed a Topamax lawsuit blaming drug manufacturer Janssen for her son’s cleft palate and lip. She also claimed the company was negligent in its failure to inform patients about the alleged risks life-altering risks to unborn babies until the U.S. Food and Drug Administration (FDA) ordered stronger label warnings in 2011.

Janssen will face the first two of 63 lawsuits regarding Topamax this month in Philadelphia.

The FDA issued a safety alert in March 2011, renaming Topamax as a Pregnancy Category D drug, which “means 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 patient medication guide and prescribing information for the drug was then updated to reflect the risks.

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