FDA OKs Morning Sickness Drug It Pulled 30 Years Ago

Pill now considered safe
By Newser Editors and Wire Services
Posted Apr 9, 2013 1:06 PM CDT
FDA OKs Morning Sickness Drug It Pulled 30 Years Ago

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. Yesterday's FDA decision means a new version of the pill once called Bendectin is set to return to US 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, says the medical director for the March of Dimes, which seeks to prevent birth defects. US sales of Diclegis are expected to begin in early June, according to Canada-based manufacturer Duchesnay Inc. The drug's main ingredients are Vitamin B6 plus the over-the-counter antihistamine doxylamine, found in the sleep aid Unisom. US obstetricians have long told nauseated pregnant women how to mix up the right dose themselves. (More Food and Drug Administration stories.)

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