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FDA Allows Return of Drug for Morning Sickness

Safety issues resolved, experts say Diclegis' return is long overdue
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WebMD News from HealthDay

By Margaret Farley Steele

HealthDay Reporter

TUESDAY, April 9 (HealthDay News) -- A morning-sickness medication that was withdrawn from the market 30 years ago has won U.S. Food and Drug Administration approval under a new name.

In its new form, the drug -- formerly called Bendectin and now renamed Diclegis -- is the only medication specifically approved to treat the stomach upset many women suffer from during pregnancy.

In the intervening decades between the drug's withdrawal from the market and its re-approval on Tuesday, the medicine has undergone rigorous scrutiny and is now deemed safe by the FDA.

Obstetricians welcomed the announcement.

"The nausea and vomiting of early pregnancy can range from mild to debilitating," said Dr. Jennifer Wu, an obstetrician-gynecologist at Lenox Hill Hospital in New York City. "Patients will welcome more options for treatment with the reintroduction of Bendectin."

Their nausea may not disappear completely, but "it will hopefully decrease to the point that a patient can function," she added.

Diclegis, which combines vitamin B6 and the antihistamine doxylamine, is a delayed-release pill that's meant to be taken daily before symptoms set in. Those symptoms are often worse after waking up, hence the name "morning sickness." But some women are plagued by nausea all day long.

The medication is intended for women whose nausea isn't "adequately managed through recommended changes in diet and lifestyle," Dr. Hylton Joffe, director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research, said in an FDA news release.

Morning sickness usually improves after the first trimester. Recommended dietary and lifestyle changes to help beat the nausea include eating several small meals instead of three large meals, eating low-fat bland foods that are easy to digest and avoiding smells that can trigger episodes.

Another expert said the drug's reintroduction was long overdue.

"This drug should have never been taken off the market in the first place," said Dr. Keith Eddelman, director of obstetrics at Mount Sinai Medical Center in New York City. "It is not a controversial drug and the data is very convincing."

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