Topamax Birth Defect Lawsuits Centralized in Philadelphia

All <"">Topamax birth defect lawsuits filed in Pennsylvania state courts have been centralized in the Philadelphia Court of Common Pleas. The lawsuits allege that Johnson & Johnson subsidiary, Ortho-McNeil Neurologics, failed to properly research the pregnancy risks associated with Topamax or adequately warn users about the drug’s association with birth defects.

Topamax, which was approved in 2004, is used to treat epilepsy and migraine headaches. This past March, the U.S. Food & Drug Administration (FDA) moved Topamax from Pregnancy Category C to Pregnancy Category D, after data indicated that women taking the drug in the early months of pregnancy face a higher risk of having a baby with an oral cleft. The Pregnancy Category D designation means that there is positive evidence of human fetal risk based on human data, but potential benefits in pregnant women may outweigh risks in certain situations.

As we’ve reported previously, other birth defects may also be associated with Topamax. The FDA’s Adverse Event Report database has received scores of reports of injuries to children believed to be associated with the use of Topamax. Many involve possible Topamax birth defects, including oral clefts, limb malformations, heart defects, cranio-facial defects, spina bifida/spinal malformations, persistent pulmonary hypertension of the newborn (PPHN).

The American Headache Society has said that women of childbearing age should be careful about using Topamax to treat migraine headaches because of its birth defect risk. The same group has also warned that Topamax can impact the efficacy of certain contraceptives that contain estrogen. As such, women should discuss with their physicians alternative options for contraception while on Topamax to avoid unplanned pregnancies.

The FDA estimates that approximately 32.3 million prescriptions for Topamax or a generic equivalent were issued from January 2007 through December 2010.

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