On May 4, 2011, the Food and Drug Administration notified the medical community and the public that there is an increased risk for the development of oral cleft (cleft lip and/or cleft palate) in infants born to women taking Topamax during the first trimester of pregnancy. Topamax had previously been classified as a Pregnancy Category C drug, approved to treat partial onset seizures (1996) and migraines (2004). Pregnancy Category C means data in animal studies has shown a potential for impairing fetal development. However, data from the North American Antiepileptic Drug Pregnancy Registry indicate a significant increase in the risk of cleft lip and/or cleft palate in fetuses exposed to Topamax during the first trimester. Mothers taking Topamax during the first trimester of pregnancy were found to be 21 times more likely to give birth to a child with cleft lip and/or palate than untreated women. Data from a United Kingdom database is similar – a sixteen-fold increase in cleft lip and/or palate in women taking Topamax during the first trimester of pregnancy.
Based upon this information, the FDA has re-categorized Topamax to Pregnancy Class D, which means there is data to indicate birth defects in humans. In an FDA statement to the public on March 4, 2011, the FDA recommends that women of childbearing age find treatment options other than Topamax due to the higher risk that a child born to mothers on Topamax will develop cleft palate. The FDA further recommends that women of childbearing age who continue to take Topamax should use effective birth control. The FDA notes that hormonal oral contraceptives may be less effective when used with Topamax.
In 2010, Ortho-McNeil, a Johnson & Johnson company, the manufacturer of Topamax, pled guilty to one count of a misdemeanor violation of the Food, Drug & Cosmetic Act for illegally promoting Topamax for uses that were not approved by the FDA and was fined $6.14 million. An affiliate of Ortho-McNeil, Janssen Pharmaceuticals, agreed to pay $75.37 million to resolve civil allegations under the False Claims Act that it illegally promoted Topamax for non-FDA approved uses.
We are currently investigating a number of claims for infants born with cleft lip and/or cleft palate who were exposed to Topamax during their first trimester of development. If you need for more information on this subject contact Roger Smith, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Roger.Smith@beasleyallen.com.
Source: U.S. Department of Health & Human Services, FDA website
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