WASHINGTON -- The FDA has approved a combination of vitamin B6 and an antihistamine for the treatment of pregnancy-associated morning sickness, the agency announced. The combination, known as Diclegis, is a delayed-release formulation of pyridoxine plus doxylamine intended for use by women with persistent symptoms that have not responded to conservative management.
Doxylamine is commonly used in over-the-counter sleep aids, and since 2004 the American College of Obstetricians and Gynecologists has backed its use along with vitamin B6 for morning sickness. "Diclegis is now the only FDA-approved treatment for nausea and vomiting due to pregnancy, providing a therapeutic option for pregnant women seeking relief from these symptoms," Hylton V.Joffe, MD, of FDA's Center for Drug Evaluation and Research, said in a news release issued Monday.
The drug was tested in a clinical trial that included 261 women enrolled between weeks 7 and 14 of pregnancy who were randomized to receive the active treatment or a placebo for 2 weeks. The study found greater symptomatic improvements in women taking Diclegis. In addition, previous observational studies have shown no evidence of teratogenic effects in exposed fetuses, FDA noted.
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Wednesday, April 10th 2013 at 1:38PM
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