Topamax Faces Lawsuit on Birth Defects Lawsuits alleging the epilepsy and migraine medication, Topamax, caused babies to be born with birth defects, including cleft lip and cleft palate, are making their way through Pennsylvania state courts. On September 16, all Topamax birth defect lawsuits filed in the state were centralized in Philadelphia Court of Common Pleas.
Recently, a growing body of evidence has indicated that women who take Topamax in early pregnancy may face a higher risk of having a child with a birth defect. In March, the U.S. Food & Drug Administration (FDA) moved Topamax from Pregnancy Category C to Pregnancy Category D, a classification that means there is positive evidence of human fetal risk based on human data. The FDA made this decision after data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicated that infants exposed to Topamax as a single therapy during the first trimester f were more likely to be born with an oral cleft – cleft lip or cleft palate.
FDA’s Adverse Event database revealed over 100 reports of possible Topamax birth defects
A recent survey of the FDA’s Adverse Event database revealed over 100 reports of possible Topamax birth defects, including 29 oral clefts, 29 limb malformations, 27 heart defects, 26 reports of other congenital defects, 23 cranio-facial defects, 15 reports of spina bifida/spinal malformations, and 5 reports of persistent pulmonary hypertension of the newborn (PPHN).
The Pennsylvania Topamax lawsuits claim that the drug caused babies to be born with a number of birth defects, including cleft lip and cleft palate, and genital malformations. 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.
Legal experts expect that litigation surrounding Topamax birth defects will continue to grow, in Pennsylvania and elsewhere.