A drug designed to treat severe morning sickness in pregnant woman has been given a new stamp of approval after spending 30 years off the market over safety concerns.
Diclegis, made by private Canadian drug company Duchesnay Inc, is a generic version of the drug Bendectin, which was approved for use in 1956.
The drug was pulled from the market in 1983 after claims from mothers who took it while pregnant that it caused birth defects in their children.
According to Reuters, the drug’s manufacturer, Merrell Dow, pulled the product not because of safety fears but because the company couldn’t afford to defend itself in court against the slew of lawsuits filed by angry parents.
After rigorous tests the claims of birth defects proved to be unfounded and the FDA has declared the drug to be a safe and effective treatment for morning sickness.
The drug contains safe levels of Vitamin B6 plus antihistamine doxylamine , which is found in the over-the-counter sleep aids like Unisom.
It’s the same combination of drugs that the American College of Obstetricians and Gynecologists issued guidelines for and called a first-line therapy.
“There’s been a lot of buzz about this. Nothing better has come along” to treat morning sickness in those 30 years, Dr. Edward McCabe, medical director for the March of Dimes, told the Associated Press.
The drug has not been tested as a treatment for Hyperemesis gravidarum, the severe form of morning sickness that struck Kate Middleton early in her pregnancy.