FDA Approves Return of Morning Sickness Pill, Once Bendectin, Now Diclegis

A controversial pill previously used to combat morning sickness is making a comeback.

Pulled off the market 30 years ago, the Food and Drug Administration recently approved the drug that was long-ago thought to produce dangerous side-effects.

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.

"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, according to ABC Local. 

"We know safety-wise, 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 Hankins' study, about 260 U.S. women with morning sickness were given either Diclegis or a dummy pill for two weeks. The Diclegis users missed on average 1 1/2 fewer days of work than their counterparts.

A price for the drug in the U.S. has not yet been determined.