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.

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.

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 nausea sets in.

In a 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 11/2 fewer days of work than their counterparts.

Duchesnay wouldn’t reveal a U.S. price.

About three-quarters of women experience at least some nausea and vomiting with the hormonal surges of early pregnancy.

About 1 percent of women undergo dangerously severe vomiting, a condition that made headlines last December when in Britain, Prince William’s wife Kate was briefly hospitalized.

An initial version of Bendectin began selling in 1956, and 33 million women around the world were estimated to have taken it before the lawsuits began. At the time, the FDA continued to call the drug safe; appeals courts ruled in favor of Bendectin maker Merrell Dow Pharmaceuticals; and eventually a U.S. Supreme Court decision would render continuing suits unlikely. But Merrell Dow declared the litigation cost too high, and quit making Bendectin in 1983.

What happened? The government estimates one in 33 babies is born with birth defects regardless of medication use during pregnancy, and studies eventually concluded that Bendectin didn’t increase that risk.

 

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