Topamax is an anti-epilepsy drug marketed by the Johnson & Johnson unit Janssen Pharmaceuticals. It received FDA approval in 1996, and is prescribed to prevent epileptic seizures and migraine headaches. While Topamax has helped many patients, it also has caused dangerous side effects and birth defects.
While Topamax was FDA-approved to treat epilepsy conditions and migraine headaches, it has been prescribed for many other uses, including:
Topamax Side Effects
Initially approved by the FDA as a Category C drug with warnings that studies on animals have shown adverse effects on fetuses, Topamax was made a Category D medication in 2011 after an alert was issued by the FDA. Some common side effects of Topamax includes:
The FDA has issued several warnings regarding the use of Topamax, outlining the following risks:
Topamax has also been shown to increase the incidents of cranial defects such as cleft lips and palates in newborn babies, prompting several costly lawsuits.
Topamax lawsuits allege that Janssen Pharmaceuticals failed to adequately warn consumers about the dangers caused by the drug, accusing the company of negligence, misrepresentation, fraud, and breach of warranty.
Topamax has been the target of three lawsuits in Pennsylvania alleging that the company failed to update the drug’s label to warn users of increased risk of birth defects. The lawsuits returned verdicts of $3 million, $4 million, and $10 million to the plaintiffs in the past several months, and a fourth Topamax case began in late February 2014. Janssen also agreed to pay more than $81 million to end a U.S. Department of Justice inquiry into off-label marketing of the drug in 2010.