The February 2014 edition of the neurology journal Continuum published a review of the issues centered on the medical management of women with epilepsy. The article reiterated the increased risks of birth defects associated with a woman's use of antiepileptic drugs while pregnant.
"In utero topiramate exposure is associated with facial clefts," the authors wrote in the section on recent findings. Topiramate is marketed by Janssen Pharmaceuticals under the brand name Topamax, an antiepileptic drug, or AED, that also is used to prevent migraines.
The authors summarized their work as follows: "Counseling points are complex for managing women with epilepsy contemplating pregnancy, including evaluation of AED choice and dose. The physician must have knowledge of the issues to enable an honest discussion and appropriate decision making in partnership with the patient."
Sometimes when the "knowledge" is information that the manufacturer either knew or should have known but failed to communicate to patients and physicians - thusly contributing to the unreasonableness of the health risk - the victim of the drug's harm may be entitled to compensation. The product liability attorneys at Reich & Binstock fight for victims whose lack of information about the increased risks helped to make them vulnerable.
The U.S. Food and Drug Administration approved Topamax in 1996. Much later, medical science picked up the ball that the manufacturer dropped. It was not until March 2011 that the FDA announced, "New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy."
A part of Topamax's prescribing information reads, "Topamax (topiramate) use during pregnancy can cause fetal harm, including an increased risk for cleft lip and/or cleft palate." An FDA-approved September 2012 Topamax medication guide included this statement: "These defects can begin early in pregnancy, even before you know you are pregnant."
Topamax lawsuits have been filed by and on behalf of victims who suffered because of the alleged unreasonable risk of the drug.
Sometimes manufacturers of drugs let patients down. In Reich & Binstock's practice, experienced attorneys lift people up by fighting for their right to just compensation for pharmaceutical injury.