Topiramate, commonly known as Topamax, is an FDA approved anticonvulsant medication used to treat patients with epilepsy who have certain types of seizures. Topiramate is also widely prescribed for the prevention of Migraine headaches and between 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.
On March 4th, 2011 the FDA released a Safety Announcement informing the public of new data that show that there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topiramate (Topamax) during pregnancy. Cleft lip and cleft palate range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking and ear infections. Surgery is often used to close the lip and palate.
Data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to Topiramate Monotherapy during the first trimester of pregnancy. The prevalence of oral clefts was 1.4% compared to a prevalence of 0.38% – 0.55% in infants exposed to other antiepileptic drugs (AEDs), and a prevalence of 0.07 % in infants of mothers without epilepsy or treatment with other AEDs.
If you or a loved one has suffered side effects from taking Topamax, fill out a case evaluation form today or call us at 1-800-604-2885 to speak with an attorney specialized in compensation advocation for those suffering from side effects relating to the intake of Topamax. Our attorneys offer free Topamax legal consultation.