March 9, 2017 | dev Topamax Quick Reference Guide Generic name topiramate Date approved 1997 (as an anticonvulsant medication) 2004 (to prevent severe migraine headaches) Manufacturer Originally developed by Ortho-McNeil Neurologics and Noramco, Inc., two subsidiaries of Johnson & Johnson Services, Inc. Status On the market Approved use Anticonvulsant Prevention of migraine headache Off-Label (non-approved) uses Weight loss Serious Side Effect Cleft palate Cleft lip Genital birth defects Fetal and skeletal deformities What is Topamax? 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. Who takes it, and for what condition? People with epilepsy who have certain types of seizures may use Topamax as a FDA-approved anticonvulsant medication prescribed to be taken alone or with other medications. Topamax is also FDA-approved for use to prevent migraine headaches, but not to relieve the pain of migraine headaches when they occur. From January 2007 through December 2010, approximately 32.3 million topiramate prescriptions were dispensed and approximately 4.3 million patients filled topiramate prescriptions from the outpatient retail pharmacies in the U.S. Topamax and Birth Defects 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. We are 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. What can you do? If you or someone you love has given birth to a child who suffers from birth defects that might be the result of Topamax or one of its generic versions, you have valuable legal rights. Please call our toll-free number (1-888-341-1405) to discuss your case with one of our Topamax injury lawyers. Trust our Massachusetts Topamax injury attorneys to help Contact the Boston law firm of Thornton Law Firm LLP online or at 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts drug and medical device litigation. You have nothing to risk. We offer a fair and accurate assessment of your case.