sales of Diclegis are expected to begin in early June, according to Canada-based manufacturer Duches...

1. FDA approves morning sickness pill that was taken off
market 30 year ago
sales of Diclegis are expected to begin in early June, according to Canada-based manufacturer
Duchesnay Inc. He was not involved in the drug's approval process. Although it often occurs upon
waking, some women have trouble all day. Nothing better has come along" to treat morning sickness
in those 30 years, said Dr.
WASHINGTONA morning sickness treatment pulled off the market 30 years ago has won Food and
Drug Administration approval again as the only drug specifically designated to treat the condition in
pregnant women.
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.
U.S. McCabe of the March of Dimes says it's important to recognize that when a drug is widely used
in pregnancy, some babies will be born with birth defects that are a coincidence.
"This drug should have never been taken off the market in the first place," Dr. 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. women with morning sickness were given
either Diclegis or a dummy pill for two weeks. A next-step option includes the drug Zofran, normally
used to treat nausea from cancer therapy.
© 2013 CBS Interactive Inc. obstetricians have long told nauseated pregnant women how to mix up
the right dose themselves.
In fact, in 2004 the American College of Obstetricians and Gynecologists issued guidelines calling
the combination a first-line therapy.
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 their nausea sets in.
The return of an FDA-cleared treatment is needed, said ACOG spokesman Dr. Keith Eddelman,
director of obstetrics at The Mount Sinai Medical Center in New York City, said in an email to
CBSNews.com. It usually ends by the second trimester, so doctors prescribing the Diclegis should
reassess whether their patients need the drug as the pregnancy progresses.
About 1 percent of women undergo dangerously severe vomiting called hyperemesis gravidarum, the
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. His next step is the B6-and-antihistamine
combination that will form Diclegis. Pills must be taken on an empty stomach.

2. In Hankins' study, about 260 U.S. Jeffrey Ecker, an obstetrician at Massachusetts General Hospital
who wasn't involved in the study of Diclegis.
"It's not magic," Ecker cautioned, saying few women see their symptoms completely disappear with
the medication. "It is not a controversial drug and the data is very convincing."
Doctors advise trying some other steps before turning to medication for morning sickness: Eat
protein snacks before bed. price.
About three-quarters of women experience at least some nausea and vomiting with the hormonal
surges of early pregnancy. Edward McCabe, medical director for the March of Dimes, who
welcomed the step.
"We know safety-wise, there's zero question," said Dr. 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. This material may not be published, broadcast, rewritten, or redistributed. But
Merrell Dow declared the litigation cost too high, and quit making Bendectin in 1983.
What happened? The government estimates 1 in 33 babies are born with birth defects regardless of
medication use during pregnancy, and studies eventually concluded that Bendectin didn't increase
that baseline risk. The Associated Press contributed to this report.
. Nibble crackers or sip ginger http://www.empr.com/zofran/drug/1495/ ale before getting out of
bed. Eat frequent small meals. The Diclegis users missed on average 1 1/2 fewer days of work than
their counterparts.
Duchesnay wouldn't reveal a U.S. Avoid nausea-triggering odors.
When that doesn't work, Ecker says vitamin B6 alone helps some women. Gary Hankins of the
University of Texas Medical Branch in Galveston, who headed one of the company-financed studies
of Diclegis that led to its approval.
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.
"There's been a lot fda zofran birth defects of buzz about this. "But for some it allows them to be
much more functional."
The starting recommended dose for Diclegis is two tablets taken at bedtime, which can increase to
up to four a day if symptoms are not controlled at a lower dose. Supreme Court decision would
render continuing suits unlikely. All Rights Reserved