RxFilter, a data aggregation and refinement process company, has suggested that two epilepsy drugs defined by the FDA as having “no known human risk” may actually be dangerous to a human fetus, according to news sources.
If the evidence is conclusive, it may prompt the Food and Drug Administration to reclassify the drug from a class C (no known human risk) to a class D, which is classified as having “positive evidence of human fetal risk.”
RxFilter analyzed the FDA’s Adverse Event Reporting System in regards to birth defects, stillbirths, and congenital abnormalities that were linked to 18 medications for epileptics.
The analysis found that Lamictal and Keppra, currently class C medications, might be as dangerous to a human fetus as a class D medicine. A comparison between the two birth defect rates found no meaningful differences. Other drugs in the analysis include: Carbatrol/Tegretol, Depacon/Kene/Kote, Dilantin, Keppra (and IR), Klonopin, Lamictal, Neurontin, Topamax, Trileptal, and Zonegran.
The study suggests that the FDA may need to reclassify some drugs, but also suggests that more studies are needed to provide conclusive evidence.
As a Los Angeles personal injury lawyer, I urge all patients to consult with their doctor before discontinuing or altering their medication. As a product liability lawyer, I hope that more studies will be conducted on these potentially harmful drugs so that the consumer can be as informed as possible when making decisions regarding their health and the health of their family.