FDA: Topamax May Pose Cleft Lip Birth Defect Risk
Written By: Rheingold, Giuffra, Ruffo & Plotkin LLP
The FDA has required Johnson & Johnson's Ortho McNeil division to change the label on the popular drug Topamax after studies have shown an increased risk of birth defects when compared to other seizure medications and the general population. The cleft lip or palate birth defects can develop in the first trimester of pregnancy. Often times women don't know that they are pregnant during the first trimester and could be causing significant harm to the fetus.
If the decision is made to use topiramate in women of childbearing age, effective birth control should be used.
It is important to contact your doctor if you're on topamax and are of child bearing age. It is important for you and your doctor to weigh the benefits and risks of taking this medication in light of the new information from the FDA.
If you have taken Topamax and your child was born with a cleft lip or palate, contact the lawyers at Rheingold, Giuffra, Ruffo & Plotkin LLP for a free consultation.