FDA Approves Morning Sickness Drug It Pulled Off The Market 30 Years Ago

You don’t have to have ever been pregnant to understand one of the yuckiest drawbacks experienced by women — morning sickness, that awful time when lunch won’t stay down and the toilet is a mom-to-be’s best friend. Thirty years ago the Food and Drug Administration put the kibosh on a treatment designed to alleviate morning sickness, the agency is putting it back on the table now.

The Associated Press is calling it a comeback (unclear whether or not LL Cool J would rule it as such) as the FDA now says a new version of a drug called Benedictin is okay to go on the market. The agency yanked it way back when after hundreds of lawsuits claimed it contributed to birth defects.

The pill will be sold under the name Diclegis in the U.S., and the FDA says it’s a safe and effective treatment for this particularly awful rite of pregnancy passage. During those years of banishment, researches have tested the treatment for safety possibly more than any other drug used in pregnancy.

“There’s been a lot of buzz about this. Nothing better has come along” to treat morning sickness in those 30 years, said the medical director for the March of Dimes, who is all about the FDA’s move to approve the drug.

U.S. sales of Diclegis are scheduled to start in early June from a Canadian manufacturer that’s been selling the pill in a generic form for years.

Here’s what’s in them that makes the pills so effective: Vitamin B6 plus the over-the-counter antihistamine doxylamine, found in the sleep aid Unisom. Apparently obstetricians have included those same ingredients when telling pregnant women how to mix up a fix for themselves.

Women will be instructed to take the pills, coated to provide a delayed-release, before the morning nausea is due to set in.

FDA approves return of drug for morning sickness [Associated Press]

Want more consumer news? Visit our parent organization, Consumer Reports, for the latest on scams, recalls, and other consumer issues.