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FDA approves return of drug for morning sickness

Now, for the first time in decades, there’s a prescription pill for morning sickness. Diclegis just got the okay from the FDA.
(CNN/WSYR-TV) -- The misery of morning sickness affects 75 percent of all pregnant women, and like most, Kimberly Palsson had no choice but to suffer through it.

Palsson says she threw up multiple times a day and was sick for at least 13 weeks of her pregnancy.

But now, for the first time in decades, there’s a prescription pill for morning sickness. Diclegis just got the okay from the FDA.

It’s a combination of vitamin B6 and the antihistamine Dosylamine. Both have been available over-the-counter as supplements or sleep aids and recommended by doctors for years.

"This pill is the same thing we've been prescribing for many years, it’s just in a different form: extended release,” said Dr. Joanne Stone with Mount Sinai Hospital in New York City.

Diclegis is the same as “Bendectin” – a prescription medication that was available in the 60s and 70s, but hundreds of lawsuits claimed it caused birth defects and although that was never proven, the makers of the drug pulled it from the market in 1983.

Now, with a new name, Diclegis is making a comeback. The makers of the pill warn it may cause severe drowsiness. The recommended dose is two tablets before bedtime.

The FDA says “observational studies have shown that the combination of active ingredients in Diclegis does not pose an increased risk of harm to the fetus,” but women still need reassurance.

"We have to explain to patients the medication was taken off the market because of concern for birth defects, but that concern was totally unfounded and pregnant women should feel comfortable taking this drug," Dr. Stone continued.

It’s still recommended that you try dietary and lifestyle changes first, things like eating smaller meals, avoid certain smells and so on. The medication is expected to be available in the U.S. in early June. It’s been available in Canada for decades under the name Declectin.

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