FDA: Morning Sickness Drug Returns After Being Pulled 30 Years Ago
The U.S. Food and Drug Administration have approved a drug to treat morning sickness that was withdrawn from the market 30 years ago amid false reports that it caused birth defects.
The decision announced on Monday means a new version of the pill once called Bendectin is set to return to U.S. pharmacies in June under a different name - Diclegis made by Duchesnay Inc, a private Canadian company, according to the report. Benedectin was s initially approved in the United States under in 1956, but later made headlines following several lawsuits from mothers claiming their children had been harmed by it.
At the time, the F.D.A. continued to call the drug safe. But its maker, Merrell Dow, declared the litigation cost too high, and quit making Bendectin in 1983.
Like Bendectin, Diclegis consists of two main ingredients: doxylamine succinate, which is contained in several over-the-counter antihistamines; and pyroxidine hydrochloride, also known as vitamin B6. Diclectin comes in the form of a single pill and will be available only with a prescription.
"There's been a lot of buzz about this. Nothing better has come along" to treat morning sickness in those 30 years, said Dr. Edward McCabe, medical director for the March of Dimes, who welcomed the step.
"We know safety-wise, there's zero question," said Dr. 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.