FDA OKs Morning Sickness Drug It Pulled 30 Years Ago
Pill now considered safe
By Newser Editors and Wire Services
Posted Apr 9, 2013 1:06 PM CDT
   (Shutterstock)

(Newser) – A treatment pulled off the market 30 years ago has won Food and Drug Administration approval again as the only drug specifically designated to treat morning sickness. That long-ago safety scare, prompted by hundreds of lawsuits claiming birth defects, proved to be a false alarm. Yesterday's FDA decision means a new version of the pill once called Bendectin is set to return to US pharmacies under a different name—Diclegis—as a safe and effective treatment for this pregnancy rite of passage.

In the intervening decades, the treatment is widely believed to have undergone more scrutiny for safety than any other drug used during pregnancy. "There's been a lot of buzz about this. Nothing better has come along" to treat morning sickness in those 30 years, says the medical director for the March of Dimes, which seeks to prevent birth defects. US sales of Diclegis are expected to begin in early June, according to Canada-based manufacturer Duchesnay Inc. The drug's main ingredients are Vitamin B6 plus the over-the-counter antihistamine doxylamine, found in the sleep aid Unisom. US obstetricians have long told nauseated pregnant women how to mix up the right dose themselves.

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Showing 3 of 7 comments
YankeeJane
Apr 10, 2013 5:28 PM CDT
I took Bendectin with both of my girls. It was heaven-sent relief for the day long nausea I experienced. Both girls are absolutely fine with no health issues. My motto has always been "better life through modern chemistry".
NavyWife54
Apr 10, 2013 9:23 AM CDT
34 years ago I took Benetictin for morning sickness. My daughter was born with Pyloric Stenosis and an ear deformity, the first requiring surgery at 5 weeks of age, the later reconstructive surgery. She had projectile vomiting from 1 week and weighed nearly a pound less than birth the day of surgery. During those 4 weeks prior to surgery, several measures were tried until an Upper GI series revealed the problem. We have no family history of this disorder and it is very uncommon in female infants. The drug was pulled shortly after this. I would not take this medication again or recommend that anyone else take it.
fractal
Apr 9, 2013 3:12 PM CDT
I would trust 2 hits of grass, over anything a pharm company puts out. Pregnant women have been using it for morning sickness for thousands of years.