Janssen Pharmaceuticals, a subsidiary company of Johnson & Johnson, was sued by April Czimmer, a resident of Virginia who took Topamax for between August 2006 and February 2007 to treat migraines. She gave birth to a boy with cleft lip in September 2007. Her son, Blake, has had four surgeries. The jury discussed the case for less than an hour before reaching their decision.
Janssen is facing at least 134 cases in Philadelphia involving Topamax birth defects. A jury trial involving a 5 year-old boy began earlier this week. Plaintiffs in the litigation allege that Janssen were negligent when they failed to adequately warn physicians and patients about the risk of birth defects.
In March 2011, the FDA updated the Prescribing Information for Topamax to warn about the increased risk of cleft lip and cleft palate. The birth defects range from a small notch on the upper lip to a massive craniofacial opening that involves the upper lip, nose, hard palate, and soft palate.
According to the FDA:
“The prevalence of oral clefts was 1.4% compared to a prevalence of 0.38% – 0.55% in infants exposed to other antiepileptic drugs (AEDs), and a prevalence of 0.07 % in infants of mothers without epilepsy or treatment with other AEDs.”
Topamax (topiramate) is an anticonvulsant drug that was approved by the FDA in 1996 to treat patients with epilepsy who have certain types of seizures. It is also approved to prevent migraine headaches.
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