Topiramate, sold under the brand name Topamax by Ortho-McNeil Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson is an anti-seizure drug that is also used to prevent migraines.  On March 4, 2011, the Food and Drug Administration (“FDA”) released an official safety alert regarding Topamax (Topiramate).  According to the FDA there is an increased risk of developing birth defects such as cleft lip, cleft palate, and genital defect in infants born to women who used the drug during pregnancy.

The FDA’s warning follows statistics released by the North American Antiepileptic Drug Pregnancy Registry that indicate an increased risk of oral clefts in infants exposed to Topamax (Topiramate) during the first trimester of pregnancy.  Based on the data, the FDA will now require a stronger warning in the drug’s prescribing information and labeling, and has changed Topamax (Topiramate) to a Pregnancy Category D drug, meaning that there is positive evidence of human fetal risk based on human data.

As early as the summer of 2008, the American Academy of Neurology published a report indicating that Topamax (Topiramate) may increase the risk of birth defects.  The study showed that infants born to women taking the drug during the first trimester of pregnancy developed oral clefts at a rate 11 times higher than those not exposed to the drug.  Neurology, The Medical Journal of the American Academy of Neurology, July 22, 2008.  Nevertheless, Topamax (Topiramate) continued to be marketed, sold, and prescribed not only as an anti-seizure medication and migraine preventative, but also for “off-label” uses such as bi-polar disorder, obesity, alcoholism, post-traumatic stress disorder, headaches, depression, and autism.

Unfortunately, because nearly half of all pregnancies are unplanned, and because facial deformities like cleft lip and cleft palate are established during the first trimester of pregnancy, women of childbearing age who take Topamax (Topiramate) during pregnancy may cause irreversible harm to their unborn child before they are even aware they are pregnant. If you are currently taking Topamax and you are pregnant or planning to become pregnant, consult your physician as soon as possible.  It is never encouraged to discontinue use of a prescription medication without consent, as this may cause further adverse side effects.  However, with the aid of your doctor, you may be able to find a safer alternative to Topamax.

The FDA estimates that approximately 32.3 million individuals filled prescriptions for Topamax or a generic form of the medication between January 2007 and December 2010. Unfortunately, a significant percentage of these prescriptions were issued to women of childbearing age.  Although nothing can be done to reverse a serious birth defect, our laws provide that victims of birth defects caused by Topamax (Topiramate) must be compensated, and the law firm of Pope, McGlamry, Kilpatrick, Morrison & Norwood, P.C. is working hard to obtain justice for Topamax birth defect victims and their families.

The goal of a Topamax lawsuit is to seek financial compensation for birth defects and related injuries, medical expenses associated with injury treatment, and the pain and suffering sustained by you and your family.  Additionally, defective drug lawsuits bring public attention to the importance of safer medications and potentially dangerous drugs that may still be on the market.  The law firm of Pope, McGlamry, Kilpatrick, Morrison & Norwood, P.C. has assembled a team of lawyers that have extensive experience with dangerous drug claims.  If you or a loved one has taken Topamax and experienced the tragedy of birth defect, our firm can help.

Disclaimer:  All use of the Topamax mark is for informational and product identification purposes only.  This post should not be taken as either medical or legal advice, but instead should act as a resource in providing general information that may be useful to the general public.  Pope, McGlamry, Kilpatrick, Morrison & Norwood, P.C. is not affiliated with the drug manufacturer Janssen Pharmaceuticals or its distributors.