April 9, 2013— -- The 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. 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. The main side effect is drowsiness," he said.
While all drugs carry at least some safety risk, Dr. 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. 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. Keith Eddelman, the director of obstetrics at the Mount Sinai Medical Center in New York City, agreed. He said the drug should never have been taken off the market in the first place.
"It is not a controversial drug, and the data is very convincing. ... 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. pharmacies in June in a new version.
Bendectin began selling in 1956. An estimated 33 million women worldwide were prescribed the drug. Once the lawsuits began, Merrell Dow, the original distributor, found the cost of defending the drug prohibitive and discontinued it in 1983. 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. 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. 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. The company also planned an educational campaign aimed at easing the worries of women taking the medication.
The drug's formula consists of vitamin B6, plus the over-the-counter antihistamine doxylamine, which is found in the sleeping aid Unisom. The prescription-only Diclegis will combine both ingredients with a time-release coating designed to help women take a daily dose before nausea sets in.
Obstetricians have long recommended that nauseated pregnant women mix a similar concoction for themselves. In 2004, the American College of Obstetricians and Gynecologists issued guidelines for the combination it called a first-line therapy.
Ashton said the drug had not been studied in treatment of Hyperemesis gravidarum, the severe form of morning sickness that put Kate Middleton in the hospital early in her pregnancy.
Ashton also recommended trying lifestyle changes, such as eating small, frequent bland snacks, acupressure wrist bands and meditation before taking medication to ease morning sickness. But if symptoms become overwhelming, Ashton said Diclegis could be a good option.
"Vomiting a few times a day may be something a pregnant woman can handle for a short period of time," she said. "Vomiting hourly is not."