Adverse Events, a California start-up company whose aim is to be a “service provider to deliver accurate, real-time information on adverse drug events reported to the FDA,” states that epilepsy drugs taken by pregnant women may be more dangerous for their unborn children than is advertised.
Some epilepsy drugs are known to cause birth defects, as well as stillbirths, in gestating fetuses.
The FDA uses a “pregnancy category” that warns which medications may cause harm to a developing fetus. The fetuses of pregnant epileptics are especially at risk because their mothers do not have an option of discontinuing their medication. Due to this, the FDA’s pregnancy category is labeled A (no known risk). B. C. D. and X (Danger – Do not use). Adverse Events believes the risks of taking these drugs have been understated and that the FDA has failed to recognize or analyze the risks after the drugs have gone to the market.
Adverse Events used their “17-step data refinement system” they call RxFilter to analyze relevant adverse event reports to the FDA’s Adverse Event Reporting System (AERS). They found that between the beginning of 2004 to March 31, 2011 there were reports filed about 18 different epilepsy drugs prescribed during pregnancy. Ten of the 18 drugs had more than 25 birth defect-related case reports.
Looking at nearly 3000 “primary suspect” cases of birth defect-related adverse events, most of them were indeed defects or malformations. There were over 500 cases of stillbirths and nearly 80 cases of cleft lip/palate. The results show that many category C class drugs were just as dangerous as category D drugs. In fact, there was really no difference between the two categories.
If your child has suffered birth defects because of side effects from a medication you are taking, please contact an experienced personal injury attorney in your area today.