WASHINGTON — A treatment pulled off the market 30 years ago won Food and Drug Administration approval again Monday as the only drug specifically designated to treat morning sickness.
That long-ago safety scare, prompted by hundreds of lawsuits claiming birth defects, proved to be a false alarm.
Monday's decision means a new version of the pill once called Bendectin is set to return to U.S. pharmacies under a different name — Diclegis — as a safe and effective treatment for this pregnancy rite of passage.
In the intervening decades, the treatment is widely believed to have undergone more scrutiny for safety than any other drug used during pregnancy.
"Nothing better has come along" to treat morning sickness in those 30 years, said Dr. Edward McCabe, medical director for the March of Dimes, who welcomed the step.
U.S. sales of Diclegis are expected to begin in June, according to Canada-based manufacturer Duchesnay Inc. The company has long sold a generic version of the pill in Canada under the name Diclectin.