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.
The medication was fast-tracked through the FDA approval process, with one major caveat: Makena's manufacturer was required to do a larger follow-up study to confirm the drug's benefit.
The follow-up study, published in late October, found Makena "did not decrease recurrent preterm births.
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