FDA takes major step in removing pregnancy drug Makena

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An advisory panel for the Food and Drug Administration recently voted 14-1 in a public hearing to have Makena, an injectable drug intended to prevent premature births, removed from the market.

A 2020 FDA decision ruled the drug ineffective; however, the manufacturer, Covis Pharma, appealed the decision and wanted to keep the drug available pending further research. The company has argued that Makena “benefits women at highest risk of early deliveries, including Black Americans” and that removing the drug would “worsen racial disparities in prenatal care,” according to the Associated Press.

Makena was initially approved in 2011 as part of the FDA’s accelerated approval process. Early data was based on a small study “in which it appeared to reduce the rate of premature birth in women with a history of the problem,” according to AP. 

FDA approval was contingent upon a larger follow-up study, but results from a 2019 study concluded that the drug did not reduce preterm births nor result in healthier outcomes for infants. Other known risks of the drug include blood clots and depression.

A final decision regarding the drug is expected from FDA Commissioner Dr. Robert Califf within the next several months. About 350,000 women have used the drug since 2011.

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