On March 7, 2011, the Food and Drug Administration announced a change in the pregnancy class of Topamax (Topiramate) from a category “C” drug to a category “D” drug. Category “D” drugs may present a risk of harm to a human fetus. The “Safety Announcement,” entitled “FDA Drug Safety Communication: Risk of Oral Clefts In Children Born To Mothers Taking Topamax (Topiramate)” provided that “[i]f you take topiramate during pregnancy, there is a higher risk that your baby will develop a cleft lip and/or cleft palate. Oral clefts happen early in pregnancy, before many women even know they are pregnant. For this reason, women of childbearing age should talk to their healthcare professionals about other treatment options.”
The FDA press release was based upon data reported by the North American Antiepileptic Drug Pregnancy Registry. According to the NAAED data, 1.4% of children born to mothers taking Topamax developed a cleft palate, as compared to 0.38 to 0.55% of children born to mothers taking different antiepileptic drugs, and 0.07% of children born to mothers without epilepsy treatment. Based upon this data, the risk of a developing a cleft palate while on Topamax is 2-3 times higher than the risk associated with similar drugs, and roughly 20 times the risk faced by the general population.
In May of 2010, Ortho-MacNeil was fined for illegally promoting Topamax. Read more in our entry entitled “Topamax Manufacturer Fined $6M By FDA For Illegal Promotion of Topiramate.”
For nearly three decades, the Bottar Leone, PLLC legal team has represented individuals and families harmed by dangerous products, including unsafe medications. If you took Topamax while pregnant and your child was born with a cleft palate or genital defect, your child may be entitled to compensation. To learn more by speaking with one of our Syracuse unsafe medication attorneys, call 800-336-5297 or email email@example.com.