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FDA approves return of morning sickness drug for pregnant women

Regulator confirms safety of Diclegis – formerly known as Bendectin

Duchesnay Diclegis morning sickness
Photo: Diclegis 10mg (PRNewsFoto/Duchesnay USA)

The US FDA has approved the return to market of a morning sickness drug for pregnant women 30 years after it was withdrawn following safety concerns.

Doxylamine succinate and pyridoxine hydrochloride was originally marketed as Bendectin in the US from 1956, but was pulled from the market in 1983 after its makers Merrell Dow faced several legal battles from people claiming the drug caused birth defects.

However, after confirming the drug's safety for unborn children, the FDA has said that Canada-based pharma company Duchesnay can market a new version of the drug called Diclegis, making it the only drug available in the US specifically to treat nausea in pregnancy.

Specifically, the regulator approved the drug for women who have not adequately responded to 'conservative management' of the symptoms, such as modifying diet to eat several small meals a deal or eating low fat food.

The approval means Duchesnay can market Diclegis as a daily delayed-release table. It is recommended two tablets are taken at bedtime, with a maximum of four tablets to be taken per day if symptoms do not improve.

Dr Shannon Clark, associate professor, division of maternal and foetal medicine at the University of Texas, said the approval has potential to help “millions of pregnant women suffering every year from nausea and vomiting of pregnancy”.

“Diclegis provides a safe and effective option for pregnant women,” she said.

The approval is based on a study involving 261 women experiencing nausea and vomiting during pregnancy, who were randomly assigned to receive two weeks of treatment with Diceglis or a placebo.

Women in the Diceglis arm demonstrated a greater improvement in these symptoms, while additional observational studies demonstrated that the drug did not pose a threat to the foetus.

Safety of a the unborn child has been a major concern in treatments for pregnant women, and one of pharma's biggest scandals involved the morning sickness drug thalidomide, which was pulled from the market after thousands of children were born with birth defects.

11th April 2013

From: Sales, Regulatory



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