Old Medicine for Morning Sickness Is Back on Market

The FDA has just re-approved an oral medicine for morning sickness. Once sold as Bendectin, the drug contains the antihistamine doxylamine and the B vitamin pyridoxine.
It was voluntarily removed from the market in 1983 by Merrell Dow Pharmaceuticals because of pending litigation claiming that the drug caused birth defects. Epidemiological studies, however, have not demonstrated a link between the combination of vitamin B6 plus doxylamine and any harm to the fetus. The FDA never banned Bendectin.
The Canadian drug maker Duchesnay Inc., submitted data from a randomized, placebo-controlled study of 261 pregnant women showing it eases nausea and vomiting. There are no other approved drugs for morning sickness available in the U. S. The re-issued medication will be called Diclegis and will arrive in pharmacies in June.