WASHINGTON - Talk about a comeback: A treatment pulled off the market 30 years ago has won Food and Drug Administration approval again 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 FDA 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.
"There's been a lot of buzz about this. 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.
"We know safetywise, there's zero question," said Dr. Gary Hankins of the University of Texas Medical Branch in Galveston, who headed one of the company-financed studies of Diclegis that led to its approval.
U.S. sales of Diclegis are expected to begin in early June, according to Canada-based manufacturer Duchesnay Inc. The company has long sold a generic version of the pill in Canada under yet another name, Diclectin.
For all the names, the main ingredients are the same: Vitamin B6 plus the over-the-counter antihistamine doxylamine, found in the sleep aid Unisom. U.S. obstetricians have long told nauseated pregnant women how to mix up the right dose themselves.
In fact, in 2004 the American College of Obstetricians and Gynecologists, or ACOG, issued guidelines calling the combination a first-line therapy.
The difference that prescription-only Diclegis would offer: Combining both ingredients with a delayed-release coating designed to help women take a daily dose before their nausea sets in.
The return of an FDA-cleared treatment is needed, said ACOG spokesman Dr. Jeffrey Ecker, an obstetrician at Massachusetts General Hospital who wasn't involved in the study of Diclegis.
"It's not magic," Ecker cautioned, saying few women see their symptoms completely disappear with the medication. "But for some, it allows them to be much more functional."
"There's been a lot of buzz about this. Nothing better has come along."
Dr. Edward McCabe, March of Dimes medical director