FDA Approves Morning Sickness Pill Once Pulled FromMarket

Keith Eddelman, the director of obstetrics at the Mount Sinai Medical Center in New York City,agreed. After this horrific episode, women were quicker to blame medications taken duringpregnancy for complications and birth defects.

Godin would not reveal pricing or sales information but said the company planned to market thedrug to physicians, nurses and midwives who offer medical advice to pregnant women. ... JenniferAshton, ABC News senior medical contributor and a practicing ob-gyn, said she believed Diclegiswas safe.

"Both pregnant women and their health care providers are always cautious when using any drugduring pregnancy because of the potential harm to the fetus. The company also planned aneducational campaign aimed at easing the worries of women taking the medication.

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The U.S. Food and Drug Administration Monday approved Diclegis, a drug used to treat pregnantwomen for morning sickness, making it thehttps://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Zofran_Oral/pdf/ZOFRAN-ORAL.PDF only FDA-approved drug to treat the pregnancy-relatedsymptoms of nausea and vomiting.

That's quite a turnaround for a drug that was yanked off the market 30 years ago after women filedhundreds of lawsuits claiming the pill caused birth defects.

Gilbert Godin, chief executive officer of Duchesnay USA, the drug's maker, said the safety fears wereunfounded and in the intervening decades, Diclegis (doxylamine succinate and pyridoxinehydrochloride) became one of the most-tested pregnancy drugs in history. This new FDA medicationis 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 bypregnant women and that both medications were similarly safe.

Monday's FDA decision means the pill, originally called Bendectin and currently sold in Canadaunder the name Diclectin, would return to U.S. Thalidomide was found to cause birth defects andbefore its removal from the marketplace in 1962, thousands of mothers who took the drug hadbabies born with malformed limbs. Godin noted that it had received the FDA's Pregnancy Category Astatus, 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. An estimated 33 million women worldwide wereprescribed the drug. Once the lawsuits began, Merrell Dow, the original distributor, found the costof defending zofran for morning sickness side effects the drug prohibitive and discontinued it in1983. 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. Studies eventually concluded thatBendectin didn't increase the baseline risk for birth defects, which is one in 33 babies, according tothe Centers for Disease Control and Prevention.

Part of the reason for the hysteria surrounding Diclegis was what previously happened withthalidomide, a drug marketed as a sleeping pill safe even for pregnant women. pharmacies in June ina new version.

Bendectin began selling in 1956. There are no 100 percent guarantees, but a rating of PregnancyCategory A is the safest level we have in our therapeutic arsenal," she said.

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