NPR

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.
A large study published in late October found that weekly injections of Makena during the latter months of pregnancy "did not decrease recurrent preterm births."

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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