ACOG Statement on FDA Proposal to Withdraw 17p Hydroxyprogesterone Caproate

Washington, D.C. — Christopher M. Zahn, MD, vice president, Practice Activities for the American College of Obstetricians and Gynecologists (ACOG), issued the following statement:

“The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) this week proposed that Makena (hydroxyprogesterone caproate injection [17-OHPC]) and generic equivalents be withdrawn from the market. As of now, Makena and its approved generic equivalents will remain on the market until the manufacturers decide to voluntarily remove the drugs or the FDA commissioner mandates removal.

“In the interim, ACOG supports the FDA’s recommendation that obstetric health care professionals discuss Makena's benefits, risks, and uncertainties with their patients to decide whether to use Makena while the FDA finalizes its decision. The need for an effective treatment for preterm birth is great. Makena and its associated generics represent the only treatment currently available to obstetrician-gynecologists to help prevent this condition.

“At this time, ACOG recommendations remain unchanged, as outlined in the Oct 2019 Practice Advisory and ACOG’s standing clinical guidance, “Prediction and Prevention of Preterm Birth”. Current guidelines in the United States recommend the use of progesterone supplementation in women with prior spontaneous preterm birth. Consideration for offering 17-OHPC to women at risk of recurrent preterm birth should continue to take into account the body of evidence for progesterone supplementation, the values and preferences of the pregnant woman and the resources available. 

“ACOG will continue to monitor the FDA process closely, while also reviewing any additional data analyses, and will issue updated clinical guidance, as necessary.”