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Boston’s Kelley Law Group, P.C. Takes on Johnson & Johnson over Failure to Warn Mothers of Topamax® Birth Defect Risks


BOSTON, MA – June 13, 2011 -- Kelley Law Group, P.C.-- -- has announced they will be filing product liability lawsuits against Ortho-McNeil Neurologics and Noramco, Inc., both subsidiaries of Johnson & Johnson, for their failure to adequately warn women of birth defect risks associated with their blockbuster drug Topamax.

Topomax (topiramate) was approved by the Food and Drug Administration (FDA) to treat epileptic seizures and prevent migraines. It is also prescribed by doctors for off-label treatment of other conditions like bipolar disorder, obesity, hypertension and alcoholism.

On March 4, 2011, the FDA issued a safety alert to medical providers and patients warning that Topamax and generic topiramate increase the risk for oral cleft birth defects like cleft lip and cleft palate, in children born to mothers who took the drug while they were pregnant.

In their warning, the FDA referred to statistics from the North American Antiepileptic Drug (AED) Pregnancy Registry. The data indicated that mothers who used Topamax (topiramate) during the first trimester of their pregnancy were more than twenty-one (21) times more likely to give birth to a baby with an oral birth defect than women who did not take Topamax.

Other studies have concluded that pregnant women who take anti-epilepsy medications, like Topamax, during their pregnancy may have an increased risk of having children who suffer from congenital birth defects. These birth defects include spina bifida, limb malformations, cleft lip or cleft palate, persistent pulmonary hypertension of the newborn (PPHN), congenital heart defects, genital birth defects and neural tube defects.

Johnson & Johnson has not announced any plans to recall Topamax in the wake of the FDA’s birth defect warning. However, the patient medication guide and warning label for Topamax and generic topiramate will be updated in accordance with the FDA’s recommendations.

“The sad truth is that birth defects could have been easily avoided if Johnson and Johnson had been more concerned with patient safety than profit. They were fully aware a woman taking Topamax may not realize she is pregnant during the first trimester of her pregnancy. And they also knew, in many cases, by the time she learns she is pregnant; the damage to the baby from Topamax would likely be irreversible. It is that inexcusable failure to properly warn women that is so egregious and reprehensible”, said Walter Kelley, Esq., a pharmaceutical and medical product liability attorney at Kelley Law Group, P.C.

In addition to the Topamax warning, the FDA also reclassified the Topamax pregnancy risk from a Pregnancy Category C to a Pregnancy Category D, which means Topamax has a proven risk of causing birth defects. Because birth defects associated with Topamax occur early in a pregnancy, the FDA has also advised women of childbearing age who are using Topamax to contact their healthcare provider to discuss the benefits and risk of taking Topamax to determine whether an alternative treatment option should be considered that carries a lower risk of congenital birth defects.

About Kelley Law Group, P.C.

Kelley Law Group, P.C., is one of the nation’s premiere product liability law firms. Headquartered in Boston, Massachusetts, they are assisting claimants Nationwide with product liability claims. They represent “the people” against insurance companies, big pharmaceutical companies and other greedy corporations that design, manufacture and profit by marketing dangerous and defective products to American families. Please visit for more information.


 birth defects
 anti-epilepsy medication

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