The FDA approved Ortho-McNeil’s anticonvulsant drug Topamax in 1996 for treating epilepsy in children and adults. Topamax is also FDA approved for treating migraines, which remains the most popular reason for prescribing the drug. In addition, alternative, off-label uses have been proposed, such as treating obsessive-compulsive disorder, addiction, and bi-polar disorder. Patent protection for Topamax expired in 2006, and currently the generic version is marketed by Mylan Pharmaceuticals.
In 2010, Ortho-McNeil was criminally fined $81.5 million after entering a guilty plea for promoting Topamax to treat off-label psychiatric disorders without following FDA requirements. However, larger concerns have materialized. Specifically, reports have begun to surface suggesting Topamax use during pregnancy may result in birth defects.
In 2008, researchers at the UK Epilepsy and Pregnancy Registry evaluated the risk of birth defects following maternal use of Topamax during pregnancy. Of 178 live births, 9% had some type of major congenital malformation. Three incidents occurred in mothers receiving only Topamax, while the remaining mothers were on some sort of polytherapy regimen which included Topamax. The primary malformation observed was the development of oral clefts, an affliction where a small notch or groove runs from the top of the mouth to the nose, and may lead to problems eating, talking, and resisting ear infections. Male newborns also displayed an increased incidence of hypospadias, an affliction where the urethra fails to develop properly.
In late 2010, the North American Antiepileptic Drug Pregnancy Registry confirmed the aforementioned results following an analysis of 6,456 pregnant women, some of whom were taking antiepileptic drugs. The prevalence of oral clefts occurred in 1.4% of newborns maternally exposed to Topamax, compared to .38-.55% in infants exposed to alternative anti-epileptic drugs. The rate for these malformations in the general population was only .07%.
In response to the concerns raised by these reports, the FDA recently changed the drug classification from Pregnancy Category C, wherein there is some evidence for the potential development of birth defects in animal studies, to Pregnancy Category D. Pregnancy Category D denotes positive evidence of birth defects in human clinical studies, but the beneficial effects of the drug may outweigh the potential risks, at least in some specific situations. The FDA further advised doctors to carefully weigh the prescribing options in women of childbearing age. If alternative treatment is unavailable, then doctors are advised to recommend the use of birth control, primarily due to evidence suggesting oral clefts occur following Topamax exposure during the first trimester of pregnancy.
- Cleft Lip
- Cleft Pallet
If you or a loved one took Topamax during pregnancy and your child was born with a birth defect, please contact Daniel P. Kondos today. Attorneys are available by phone, e-mail, or by clicking here.