This is Michael Brady Lynch, lead trial attorney at The Michael Brady Lynch Firm.
I predict this will soon explode into a public health disaster. Will all the off label use of Topamax, there are hundreds of thousands of prescriptions written every year.
Today, the U.S. Food and Drug Administration (FDA) informed 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 Topamax during pregnancy.
Because of new human data that show an increased risk for oral clefts, Topamax is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks. In my view, this category change does not go far enough, but it is a start.
Another huge problem with Topamax is the very small window in which the defect develops. If you take Topamax during pregnancy, there is a higher risk that your baby will develop a cleft lip and/or cleft palate. Oral clefts happen early in pregnancy, before many women even know they are pregnant.
If you or someone you know has taken Topamax and given birth to a child with a cleft lip or cleft palate, please contact me directly for a free, no-obligation evaluation of your claim.
About the Firm: The Michael Brady Lynch Firm is a trial firm with a focus on pharmaceutical mass tort cases involving SSRI and Anti-Seizure Medication Birth Defects such as Lexapro, Zoloft, Effexor, Prozac, Celexa, Paxil, Depakote and Topamax, as well as Actos Bladder Cancer and Fosamax Femur Fractures, and medical device cases including DePuy Hip and Trans-Vaginal Mesh cases. Contact us today if you or someone you know has experienced side effects involving these products.