Topamax (Topiramate) was first approved by the FDA in 1996 is an anticonvulsant used to treat epilepsy in children and adults. It won approval from the FDA in 2004 for the treatment of migraine headaches in adults.
In March of 2011 the FDA reported that when it was compared to alternative anticonvulsive medications, women who took Topamax (Topiramate) while pregnant had more than double the risk having a child with oral clefts (cleft lip or cleft palate) or other adverse birth defects. The biggest risk for birth defects caused by Topamax use while pregnant occurs during the first trimester. Because mothers taking Topamax for epilepsy or migraines may not be aware they are even pregnant until they are well into the first trimester, the FDA required the maker to update the warning label on Topamax. Topamax was reclassified from a Category C drug to a Category D drug – meaning there is “positive evidence of human fetal risk.”
The FDA Topamax warning urged doctors to use alternatives to Topamax for treatment of epilepsy and migraines for pregnant women and women of child bearing age who may become pregnant while taking Topamax. According to the FDA, Topamax is most harmful to women in their first trimester when the lip or palate of the fetus may not fuse correctly.
Prior to the FDA warning about Topamax and increased risk of birth defects such as cleft palate and cleft lip, the drug was widely prescribed to female patients, including expectant mothers. Between 2007 and 2010 over 4 million patients in the USA received over 32 million prescriptions for Topamax. The fetuses that were exposed to Topamax were three times more likely to have oral defects like cleft palate or cleft lip compared to fetuses exposed to other seizure medications.
In 2010 the makers of Topamax plead guilty to a 2003 charge by the US government that the manufacturer illegally marketed Topamax for unapproved off label use. The Topamax maker settled for $81 million. Because clinical reports indicate that Topiramate may have mood stabilizing properties, off label and investigational uses of Topiramate includes treatment of bipolar disorder, posttraumatic stress disorder, weight gain, alcoholism, and obsessive compulsive disorder (OCD). Off-label use of Topamax placed even more expectant mothers at risk of having a child born with birth defects such as cleft lip and cleft palate.
Topamax was originally categorized as a Category C drug for pregnancy risk. This means that Topamax was found during clinical study to be associated with miscarriages, decreased fetus weight in lab animals, and birth defects. Because the FDA classified Topamax as a Category C drug, the makers of Topamax had sufficient warning that Topamax may potentially cause birth defects in humans. The Topamax manufacturer did little to do more research into the risks of birth defects cause by Topamax use.
The manufacturer should be held liable for selling Topamax without including a warning label for women who are pregnant or who may become pregnant outlining the risks for Topamax related oral defects.
If you or a loved one has taken Topamax or Topiramate while pregnant and had a child suffering from cleft palate, cleft lip, or other birth defect, you may be entitled to compensation for medical expenses, pain, suffering, and more. Speak to a Topamax Lawsuit Attorney by filling out the Free Case Evaluation request on this page or by calling 800-507-6230.