Topamax Warnings and Reviews

In 1996, Ortho-MacNeil Pharmaceutical, a subsidiary of Johnson & Johnson, began marketing the drug Topamax for the treatment of epilepsy and for prevention of seizures.   However, it wasn’t until March 2011 that the U.S. Food and Drug Administration (FDA) finally issued a warning against the anti-epileptic drug because of its association with causing oral cleft birth defects in the developing fetus.  This means that for the past 15 years, women taking Topamax during pregnancy were at risk for having children with congenital defects, yet Ortho-MacNeil chose to take no action.   These allegations have grounds for a possible Topamax lawsuit. 

Cleft lips and cleft palates are oral congenital defects that cause an opening in the mouth of the fetus that splits the upper lip or the roof of the mouth known as the palate.  A cleft lip may reach the edge of the lip and even up to the nose, while cleft palates may affect both the soft and hard palate of the mouth.   Both these oral congenital defects have complications which include difficulty feeding, ear infections leading to hearing loss, problems with forming sounds or speaking, and behavioral problems.   While oral clefts can be corrected surgically, they may require multiple procedures over the course of several years.

 According to recent FDA data, since 2007 more than 32 million Topamax prescriptions have been filled.  Subsequently, millions of women for the past 15 years could have taken Topamax during their pregnancy without knowing the harm the drug could have produced.  In the FDA warning, fetuses exposed to Topamax had a 1.4 percent rate of oral defects, which is three times more than risks associated with other seizure drugs.  Topamax was classified as Category C drug for pregnancy at the time it was first listed, indicating the association with miscarriages, birth defects, and decreased fetal weight in laboratory animals.  While there were no adequate human clinical trials for Topamax when it was first marketed, a Category C classification should have required further studies as to the possible effects on humans and the possibility of causing birth defects in fetuses before being distributed.   Unfortunately, no action for further clinical trials was conducted by Johnson & Johnson or Ortho-MacNeil Pharmaceutical.

Ortho-MacNeil Pharmaceuticals and Johnson & Johnson knew about the potential risk for congenital defects associated with Topamax, but failed to do further studies or issue appropriate warnings to the public.  These companies should be held accountable and liable for the damages they have caused.   Women who took Topamax during pregnancy and gave birth to children with congenital oral defects should seek compensation for medical expenses, which will include future corrective surgical procedures, as well as pain and suffering resulting from the use of this drug.