FDA Approves Morning Sickness Pill Once Pulled From Market
1. FDA Approves Morning Sickness Pill Once Pulled From
Market
Keith Eddelman, the director of obstetrics at zofran lawsuit filed the Mount Sinai Medical Center in
New York City, agreed. There are no 100 percent guarantees, but a rating of Pregnancy Category A
is the safest level we have in our therapeutic arsenal," she said.
Dr. He said the drug should never have been taken off the market
http://www.livescience.com/42890-zofran.html in the first place.
"It is not a controversial drug, and the data is very convincing. The main side effect is drowsiness,"
he said.
While all drugs carry at least some safety risk, Dr.
The U.S. pharmacies in June in a new version.
Bendectin began selling in 1956. Thalidomide was found to cause birth defects and before its
removal from the marketplace in 1962, thousands of mothers who took the drug had babies born
with malformed limbs. An estimated 33 million women worldwide were prescribed the drug. Studies
eventually concluded that Bendectin didn't increase the baseline risk for birth defects, which is one
in 33 babies, according to the Centers for Disease Control and Prevention.
Part of the reason for the hysteria surrounding Diclegis was what previously happened with
thalidomide, a drug marketed as a sleeping pill safe even for pregnant women. Jennifer Ashton, ABC
News senior medical contributor and a practicing ob-gyn, said she believed Diclegis was safe.
"Both pregnant women and their health care providers are always cautious when using any drug
during pregnancy because of the potential harm to the fetus. The company also planned an
educational campaign aimed at easing the worries of women taking the medication.
2. . After this horrific episode, women were quicker to blame medications taken during pregnancy for
complications and birth defects.
Godin would not reveal pricing or sales information but said the company planned to market the
drug to physicians, nurses and midwives who offer medical advice to pregnant women. ... Godin
noted that it had received the FDA's Pregnancy Category A status, which is reserved for
pharmaceuticals that have failed to show risk to the fetus during well-controlled human trials.
"Contraindications to the mother are also modest. Once the lawsuits began, Merrell Dow, the
original distributor, found the cost of defending the drug prohibitive and discontinued it in 1983.
This new FDA medication is a great option for pregnant women suffering from morning sickness," he
said.
Eddelman added that Zofran, a drug approved for nausea in cancer patients, was widely used by
pregnant women and that both medications were similarly safe.
Monday's FDA decision means the pill, originally called Bendectin and currently sold in Canada
under the name Diclectin, would return to U.S. Food and Drug Administration Monday approved
Diclegis, a drug used to treat pregnant women for morning sickness, making it the only FDA-
approved drug to treat the pregnancy-related symptoms of nausea and vomiting.
That's quite a turnaround for a drug that was yanked off the market 30 years ago after women filed
hundreds of lawsuits claiming the pill caused birth defects.
Gilbert Godin, chief executive officer of Duchesnay USA, the drug's maker, said the safety fears were
unfounded and in the intervening decades, Diclegis (doxylamine succinate and pyridoxine
hydrochloride) became one of the most-tested pregnancy drugs in history
