FDA Warns of Oral Birth Defects Due To Topamax
On March 4, 2011, the US Food & Drug Administration released a warning about oral birth defects in children born to mothers taking Topamax (topiramate). The warning noted that new data suggest that Topamax and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who ingested the drug during pregnancy.
Cleft lip and cleft palate are birth defects that occur when parts of the lip or palate do not completely fuse together during the first trimester of pregnancy. Unfortunately, many women do not know they are pregnant during this early stage of pregnancy. Thus, many mothers may continue taking Topamax without realizing the risk to their unborn children.
The FDA suggested that physicians should warn all women of the risk of injury during pregnancy before prescribing Topamax.
What is Topamax?
Topamax (generically--topiramate) is in a class of medications called anticonvulsants and is used to treat seizures. It is often used to treat patients who continue to have seizures even after taking other anti-seizure medications. Additionally, Topamax is sometimes prescribed to prevent migraine headaches, although it is not used to relieve pain once a migraine headache has occurred.
Who makes Topamax?
Topamax was originally produced by Ortho-McNeil Neurologics and Noramco, Inc.-both divisions of Johnson & Johnson. Generic versions of the drug are available in Canada and are produces in the US by Mylan Pharmaceuticals.
On May 21, 2010, Ortho-McNeil pled guilty and was fined more than $6 million for violations of the Food, Drug & Cosmetic Act. The company was found to have improperly promoted Topamax to treat psychiatric disorders, without applying for any approval and without any well-controlled clinical trial to demonstrate that Topamax was safe and effective to treat any psychiatric conditions.
Do you have a claim?
Clark, Perdue & List has substantial experience with pharmaceutical injury claims. If you were prescribed Topamax before or during pregnancy, and your baby was born with a cleft palate or cleft lip, you may have claim. Contact the Ohio Topamax attorneys at Clark, Perdue & List or call us at 1-866-603-1668 today.
