FDA Approves Return of Drug for Morning Sickness
WASHINGTON (AP) — A treatment pulled off the market 30 years ago has won Food and Drug Administration approval as the only drug specifically designated to treat morning sickness.
That long-ago safety scare proved to be a big false alarm.
Monday's decision means a new version of the pill once named Bendectin will return to U.S. pharmacies — this time called Diclegis.
U.S. doctors have had no officially approved treatment for morning sickness since lawsuits forced Bendectin off the market in 1983. But the drug's main ingredients are vitamin B6 (pyridoxine) and an over-the-counter antihistamine called doxylamine (Unisom), and obstetricians often advised pregnant women how to mix up the right dose themselves.
Diclegis is made by a Canadian company that has long sold the medication in that country, and plans to begin U.S. sales in June.
Posted: April 2013