Topamax Cleft Palate Lawyer for Oral Birth Defects
The FDA has announced a strengthened warning for Johnson & Johnson's Topamax and its generics after current scientific data has shown that taking the drug during pregnancy leads to an increased risk of oral birth defects such as cleft palate and cleft lip Teva Pharmaceutical Industries Ltd, Watson Pharmaceuticals Inc., Mylan Inc., and other drug makers sell the drug under its chemical name topiramate.
In July 2008, a study was published in the journal "Neurology" that found that babies born to women taking Topamax during pregnancy had an increased risk of being born with birth defects, especially cleft palate and genital birth defects. However, not until March 4, 2011, did the Food & Drug Administration (FDA) decide to increase the warning on the dangerous drug.
Topamax is an anticonvulsant drug produced by Ortho-McNeil Neurologics, a division of Johnson & Johnson. Generic versions of Topamax were approved by the FDA in 2006. Topamax is approved to treat epilepsy and migraine headaches. It is also used off-label to treat bipolar disorder.
When it was approved, Topamax received a pregnancy category C classification from the FDA, which means the drug had not yet been studied in pregnant women. The medication did cause harm to the fetus in animal studies. The drug caused birth defects, miscarriages, and decreased fetal weight in rabbits, rats and mice. Given the fetal harm in animal studies, Topamax manufacturers could have and should have performed further scientific studies to determine its effects on human fetuses. If that had been done, the drug maker would have been forced to include stronger warnings about the possible dangers associated with taking this medication during pregnancy.
Topamax has become one of the most widely prescribed drugs for migraine headaches. Women are three times more likely to suffer from migraines than men, especially during the ages within which they would have children. Additionally, Topamax has an off-label use for obesity treatment.
Even more birth defects occurred in women taking Topamax along with the drug valproate, sold as Depakote by Abbott Laboratories. Previous research has shown that valproate is associated with an increased risk of birth defects such as heart defects and spina bifida.
The researchers who conducted the study said that the connection between Topamax and birth defects warrants further study.
Legal Help for Topamax Birth Defects
If you or a loved one has given birth to a child who suffers from birth defects that might be the result of Topamax or Depakote use, you may have a legal claim. Please contact Schechter, McElwee, Shaffer & Harris, L.L.P. today at info@smslegal.com or complete our contact form on this website.
