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Topamax Classified at a Pregnancy D Drug by the FDA

By December 20, 2012November 1st, 2017Pharmaceutical litigation, Topamax, Uncategorized

topamax_birth_defects_lawsuit_litigation_pregnancy_d_migraines_cleft_lipThere is a strong link between the use of Topamax by pregnant women and the development of a cleft lip or a cleft palate in their unborn child. Quite often, these oral defects occur during the first trimester of pregnancy, sometimes before women suffering from epilepsy even know that they are pregnant.

In a safety communication released by the U.S. Food and Drug Administration (FDA) regarding the safety of Topamax, the FDA concludes that “there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with topiramate (Topamax and generic products) during pregnancy.”

Due to their review of human data pertaining to the safety of Topamax, the FDA has re-classified Topamax from a Pregnancy C Drug to a Pregnancy D Drug. This classification as a Pregnancy D Drug results from Topamax studies that demonstrate “positive evidence of human fetal risk”, according to the FDA.

In a study conducted by the UK Epilepsy and Pregnancy Register, data demonstrates a significantly increased risk of the development of a cleft lip or a cleft palate in children exposed to Topamax in the womb. In fact, the UK Epilepsy and Pregnancy Register data shows a 16-fold increase in the risk of children developing a cleft lip or a cleft palate following exposure to Topamax in the womb compared to the rest of the population.

If your child was born with an oral defect, such as a cleft lip or cleft palate, as a result of exposure in the womb to Topamax, contact an experienced birth defect attorney at Carey Danis & Lowe today for a free legal consultation. You may be entitled to receive compensation for your and your child’s physical and emotional suffering, and for your financial and medical losses.

For more information about filing a Topamax lawsuit, contact Carey Danis & Lowe at 800.721.2519.