In the Wall Street Journal’s recent article Can Mom’s Medicine Hurt the Baby? the subject of drug classifications is discussed. They report that the FDA is “drafting new guidelines to help drug makers find ways to include pregnant women in clinical trials.”
The current ratings system that is often criticized was set up in 1979 by the FDA. It is a guide for drug use and pregnancy based on what limited data exists. Category A, means that large, well-controlled studies have shown safety for human fetuses. There are almost no Category A drugs. Exposing pregnant women and unborn babies to potential risks of clinical drug trials is dangerous and unethical. Category B drugs are believed safe but have less evidence.
Zoloft– along with the majority of prescription medication– falls into Category C. There is no information on the risk to human fetuses, but animal research shows adverse effects.
The FDA has encouraged drug companies and other groups to set up registries to monitor pregnant women and their babies who do take prescription medications. About 40 such registries currently exist and have alerted the FDA to some possible drug dangers.
If you or a loved one have taken Zoloft while pregnant, then please contact us today.