FDA Approves Morning Sickness Pill Once Pulled From Market

Keith Eddelman, the director of obstetrics at the Mount Sinai Medical Center in New York City, agreed. ... Once the lawsuits began, Merrell Dow, the original distributor, found the cost of defending the drug prohibitive and discontinued it in 1983. 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. 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. pharmacies in June in a new version.Bendectin began selling in 1956. 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 http://www.pdr.net/drug-summary/zofran-injection?druglabelid=243 - http://www.pdr.net/drug-summary/zofran-injection?druglabelid=243 - in Canada under the http://zofranrecallcenter.com/ - zofran birth defects lawsuits - name Diclectin, would return to U.S. 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 U.S. An estimated 33 million women worldwide were prescribed the drug. 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. 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. 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. The main side effect is drowsiness," he said.While all drugs carry at least some safety risk, Dr. 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 company also planned an educational campaign aimed at easing the worries of women taking the medication.. 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