Makena (hydroxyprogesterone caproate injection), the only drug approved by the Food and Drug Administration (FDA) for preventing preterm birth, has been withdrawn from the market based on clinical trial findings suggesting it is not effective. According to the Centers for Disease Control and Prevention, about one in 10 infants in the United States is preterm (born before 37 weeks of pregnancy).1

Makena was granted accelerated approval in 2011. The postmarketing clinical trial sponsored by the drug's manufacturer was a double-blind, placebo-controlled, international trial involving women who had a previous preterm singleton birth: 1,130 women received Makena and 578 women received placebo. The study concluded that Makena did not decrease the number of preterm births, and that there were no differences in the frequency of fetal/early infant deaths or in maternal outcomes between those who received Makena and those who received placebo.2

In October 2020, the FDA's Center for Drug Evaluation and Research proposed that Makena be withdrawn from the market based on the trial's findings. However, the drug was allowed to remain on the market while the manufacturer appealed the decision. Two years later, in October 2022, the FDA's Obstetrics, Reproductive and Urologic Drugs Advisory Committee met to hear the appeal and vote on whether they would recommend that Makena remain on the market; 14 voted no and one voted yes. (For more on the advisory group meeting, go to http://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-infor.)

In April 2023, the FDA announced that Makena would be withdrawn from the market. This decision affects both the brand name Makena and its generic formulations. The drug can no longer be distributed in interstate commerce.

To read the FDA News Release regarding Makena, see http://www.fda.gov/news-events/press-announcements/fda-commissioner-and-chief-sc.

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