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Our firm is currently reviewing cases involving women who took Topamax® or one of its generic versions while in their first trimester of pregnancy and had a baby born with an oral cleft lip and/or cleft palate or serious fetal or skeletal malformations. Topamax (topiramate) is a prescription drug approved for use in the United States to treat both epilepsy and severe migraine headaches. An off-label use for Topamax is as a weight loss treatment.
On March 4, 2011, the FDA announced that, based on new data from the NAAED Pregnancy Registry, Topamax will be reclassified from a Pregnancy Category C to a Category D. The new data suggests that babies exposed to Topamax during the first trimester of pregnancy have a significant increased risk of cleft lip and cleft palate, as well as genital deformities and other fetal or skeletal malformations. These findings follow a 2008 study by the medical journal Neurology that reported similar findings linking Topamax to an unusually high rate of serious birth defects like oral clefts.
Topamax Side Effects
The following injuries or side effects in babies have been associated with the prenatal, first-trimester use of Topamax:
- Cleft lip
- Cleft palate
- Genital defects
- Fetal and skeletal deformities
Topamax History
One of the best-selling prescription drugs in the United States, Topamax has grossed more than an estimated two billion dollars. The prescription drug was originally developed by Ortho-McNeil Neurologics and Noramco, Inc., two subsidiaries of Johnson & Johnson Services, Inc., and approved by the FDA in 1997 as an anticonvulsant medication to treat patients with epilepsy who have specific types of seizures. In people ten years and older, Topamax is prescribed to treat partial onset seizures and primary generalized tonic-clonic seizures. The drug is used with other medications to treat these same types of seizures, as well as a seizure and developmental delay disorder known as Lennox-Gastaut Syndrome, in people two years and older. In 2004, the FDA approved Topamax for adults only to help prevent migraine headaches.
Generic versions of Topamax have been available on the U.S. market since 2009 and are manufactured by companies that include: Apotex, Aurobindo Pharma, Barr Laboratories, CIPLA, Cobalt Laboratories, Glenmark Generics, Invagen Pharmaceuticals, Mylan Pharmaceuticals, Par Pharmaceuticals, Pliva Hrvatska, Ranbaxy Laboratories, Roxane Laboratories, Sun Pharmaceuticals, TEVA Pharmaceuticals USA, Torrent Pharmaceuticals, Unichem Laboratories and Zydus Pharmaceuticals USA.
Topamax and Birth Defects
On March 4, 2011, the FDA received new data from the NAAED Pregnancy Registry that prompted it to announce a reclassification of Topamax and its generic topiramate versions from a Pregnancy Category C to a Category D. A pregnancy Category D means that there is positive evidence of risk to an unborn baby based on concrete, human data, and a stronger warning label will be added to the drug about its effect on pregnancies.
According to the new data, babies exposed to Topamax during the first trimester of pregnancy have an increased risk of cleft lip and cleft palate, as well as genital deformities and other fetal or skeletal deformities. According to the FDA announcement regarding the study, babies born to women who took Topomax during the first trimester had a cleft lip or palate approximately 1.4 percent of the time as opposed to a rate of between .33 and .55 percent when compared to other epilepsy drugs—a significant increase in risk. Cleft lips and cleft palates occur when parts of the lip or palate fail to completely fuse together, a condition that can vary in severity and lead to serious infections and problems talking or even eating.
In July 2008, the medical journal Neurology also published a study linking Topamax to birth defects, finding that women who took the drug during early pregnancy were approximately 11 times more likely than a woman in the general population to have a baby with a cleft lip or palate and 14 times more likely to have a baby born with a genital defect.
Women of childbearing age are being advised by the FDA to speak with a doctor about benefits and risks of Topomax and whether alternative medications can be considered that carry a lower risk of birth defects.
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