-- Margaret Farley Steele
TUESDAY, April 9 (HealthDay News) -- A morning-sickness
medication that was banned 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
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
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
"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
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
Duchesnay has not yet released a price for Diclegis, the
The American College of Obstetricians and Gynecologists has more
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