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FDA approves return of nausea treatment

The only drug specifically designed for the treatment of morning sickness in pregnant women will be back on the market in June of this year. The treatment was pulled from shelves thirty years ago but a thorough investigation finds the drug safe and the FDA gave its approval yesterday.

“This is fabulous news,” says Dr. Stephanie Freeman of MomDoc Women For Women, with 15 offices throughout the Valley. “Obstetricians have been using Unisom as an off label medication for pregnancy related nausea for years, and the ingredients are similar.  To have Bendectin back as an option will provide relief of pregnancy related nausea for many women without as much of the sedation side effects of many medications we use now.”

FDA approval means a new version of the drug formerly known as Bendectin will return to United States pharmacies under a different name, Diclegis. The drug is considered safe and effective in treating nausea. In the thirty years since it was removed, the treatment has undergone more scrutiny for safety than any other drug used during pregnancy.

The original scare came from lawsuits claiming the drug caused birth defects. What the research found is that there are any given numbers of pregnancies which result in children with birth defects. Government estimates are 1 in 33 babies are born with birth defects regardless of medication used during the pregnancy. Studies concluded that Bendectin did not increase that risk.

More than half of all women experience at least some nausea and vomiting during pregnancy caused by hormonal swings. Only about one percent of women experience severe vomiting called hyperemesis gravidarum, the condition which hospitalized Britain’s Duchess of Cambridge Kate last year.

The treatment’s ingredients are not magical. Vitamin B6 and over-the-counter antihistamine doxylamine found in some sleep aids are the main ingredients. The difference with this prescription only drug is that the ingredients are released in a delayed-reaction coating designed for daily dosage before nausea is a problem.

Doctors do advise trying alternatives first including eating protein snacks before bed and nibbling crackers or sipping ginger ale before getting out of bed. Frequent, small meals seem to help some women as well.