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Premature Birth Medication Makena Doesn't Work, Research Shows


Some new research finds that a medication to prevent premature birth does not work. Now an independent panel of advisers to the FDA says it should be taken off the market. NPR's Patti Neighmond has this story.

PATTI NEIGHMOND, BYLINE: The medication is a synthetic form of the hormone progesterone, brand named Makena. Dr. Eva Pressman is chair of obstetrics and gynecology at the University of Rochester Medical Center.

EVA PRESSMAN: We think that progesterone acts as a uterine muscle relaxant.

NEIGHMOND: Which decreases the ability of the uterus to contract and can reduce the risk of premature birth. Women at risk of early delivery receive weekly injections of the drug starting at four or five months of pregnancy. Initial research found it was highly beneficial.

PRESSMAN: In women at high risk, based on having had a previous preterm birth, was significantly decreased by these weekly injections.

NEIGHMOND: The rate of preterm birth dropped by 66%. The drug was quickly approved by the FDA, with one caveat - the manufacturer had to do a follow-up study. And that one found no difference between women taking the medication and those on a placebo. Dr Vivian Lewis chaired the advisory panel. She says it was a close vote. Nine people voted to withdraw the drug from the market.

VIVIAN LEWIS: And seven people voted to leave it on the market but require additional study.

NEIGHMOND: The majority ruled and recommended that the drug be pulled. The FDA doesn't have to follow the recommendation. But typically, it does. Dr. Christopher Zahn with the American College of Obstetricians and Gynecologists says that would be a mistake. It's the only medication now available to prevent preterm birth, which causes a host of tragic problems for babies.

CHRISTOPHER ZAHN: Breathing or respiratory problems, significant prematurity, can lead to organ dysfunction, difficulty with vision and hearing, neurodevelopmental delay.

NEIGHMOND: Zahn points out that the original study did show the drug helped women at high risk of premature delivery. And he wants to see more research before it's taken off the market. Patti Neighmond, NPR News. Transcript provided by NPR, Copyright NPR.

Award-winning journalist Patti Neighmond is NPR's health policy correspondent. Her reports air regularly on NPR newsmagazines All Things Considered, Morning Edition, and Weekend Edition.

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