(WASHINGTON) — The FDA has approved the return of a morning sickness drug once linked to birth defects. The new version of the pill, now named Diclegis, was approved Monday after initial safety concerns about the drug were deemed a false alarm. The drug was pulled off the market 30 years ago.
“There was a liability concern and the maker of the drug at the time was concerned because of the lawsuits and voluntarily took the drug off the market,” explained Dr. Edward McCabe of the March of Dimes. He said he believes the drug’s early safety concerns were a false alarm.
“If you use a drug enough, you’re going to see that there are babies born with birth defects but that’s because babies are born with birth defects without or without the drug,” McCabe said.
Now the only FDA-approved treatment for nausea and vomiting due to pregnancy, Diclegis was studied in 261 women experiencing morning sickness. Researchers in the clinical trial found that women taking Diclegis experienced more relief from their symptoms of morning sickness than the women taking the placebo. They also found that the combination of active ingredients in the drug “does not pose an increased risk of harm to the fetus,” an FDA release said.
Though morning sickness is common in pregnant women, McCabe said the drug’s approval is good news to moms who suffer from more severe symptoms.
“The casual term morning sickness is kind of treated almost as a rite of passage for pregnancy, but it really can compromise women’s ability to function,” said McCabe. “If you can keep women out of the emergency department, if you can have them function, that’s just so much better.”
Copyright 2013 ABC News Radio
Kent Larson, KSL.com
Jen Christensen, CNN