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Can Makena Prevent Premature Birth? FDA panel votes "No", but some doctors disagree: photos



A large study published in late October found that weekly injections of Makena in the last months of pregnancy "do not reduce recurrent preterm births".

Jill Lehmann Photography / Getty Images


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Jill Lehmann Photography / Getty Images

A large study published in late October found that weekly Makena injections in the last months of pregnancy "do not reduce recurrent preterm births."

Jill Lehmann Photography / Getty Images

An independent panel of advisers to the Food and Drug Administration recommended last week that medicines to prevent preterm birth should be removed from the market because, according to advisers, the preponderance of the evidence suggests that it does not work. But some other leading OB-GYNs say they hope the FDA does not accept the panel's advice this time.

The drug is a synthetic form of the hormone progesterone, branded Makena.

"It was really difficult to vote," says Dr. Vivian Lewis, professor of obstetrics and gynecology at the Medical Center of the University of Rochester in New York and chairman of the FDA Advisory Board. The panel is made up of 16 people, including doctors from several specialties and statisticians.