As stated in a recent article from Pro Publica:
“Most Drugs Aren’t Tested on Pregnant Women. This Anti-nausea Cure Shows Why That’s a Problem.
For years, Zofran was the most popular morning-sickness medication in the U.S. Now it’s being accused of causing birth defects. The larger issue is a drug-safety system that excludes women from clinical trials, potentially putting them and their babies at risk.
But plaintiffs’ lawyers argue that drug makers have a heightened responsibility to assure that medications likely to be used in pregnancy are safe — especially if they are used to treat a condition as common as morning sickness, and if they are marketed off-label.