"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."
Another drug, Zofran, which is approved for nausea in cancer patients, is widely used for pregnancy, Eddelman said. "I think both of these medications are similar in safety," he added.
Bendectin was widely prescribed after its introduction in 1956, but costly lawsuits claiming safety issues caused the drug's maker, Merrell Dow, to pull it from the market in 1983.
Since then the drug has gone through rigorous testing. For this new approval, the FDA studied Diclegis in 261 women experiencing morning-sickness symptoms related to pregnancy. The women were between seven and 14 weeks of pregnancy and were randomly assigned to receive two weeks of treatment with Diclegis or a placebo, the FDA said.
The researchers found that women taking Diclegis experienced greater symptom relief than those taking placebo and missed fewer days of work.
In other studies, the combination of active ingredients in Diclegis were not found to pose an increased risk of danger to the fetus, the FDA said. However, side effects can include severe drowsiness or sleepiness.
Diclegis is marketed by the Quebec-based firm Duchesnay Inc. The company sells a generic version of the pill in Canada under the name Diclectin. U.S. sales of Diclegis are expected to start in June.
Duchesnay has not yet released a price for Diclegis, the Associated Press reported.
The American College of Obstetricians and Gynecologists has more about morning sickness.
-- Margaret Farley Steele
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