Controversy Kicks Up Over A Drug Meant To Prevent Premature Birth
An expert panel wants the Food And Drug Administration to withdraw its approval for Makena, because a large study shows the drug doesn't work. But some doctors say the evidence isn't clear-cut.
by Patti Neighmond
Nov 04, 2019
3 minutes
An independent panel of advisers to the Food and Drug Administration recommended last week that a medication to prevent preterm birth be taken off the market because, the advisers decided, the preponderance of evidence suggests it doesn't work. But some other leading OB-GYNs say they hope the FDA won't take the panel's advice this time.
The medication is a synthetic form of the hormone progesterone, brand-named Makena.
"It was a really hard vote" says , professor emerita of obstetrics and gynecology at the University of Rochester Medical Center
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