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ACOG Statement on FDA Committee Recommendation to Withdraw 17p Hydroxyprogesterone Caproate


Washington, D.C. – "ACOG is aware of the recommendation from the Obstetrics, Reproductive and Urologic Drugs Advisory Committee to withdraw FDA approval of Makena and its generic equivalents (17-OHPC). The committee's recommendation was based on results from the postmarket confirmatory trial data in the PROLONG study, released in October 2019. Pending an FDA final determination as to the status of 17-OHPC, ACOG's current guidance, ‘Prediction and Prevention of Spontaneous Preterm Birth,’ will remain in effect.
"Currently, 17-OHPC represents the only FDA-approved medication to help prevent recurrent spontaneous preterm birth. There is a clear, demonstrable need for an effective intervention to help prevent recurrent preterm birth in individuals who are at risk, including Black and Indigenous individuals who have a higher incidence and risk of preterm birth. Additional research addressing the challenges of preterm birth prevention and treatment and identifying more clearly the groups for which 17-OHPC would be beneficial is still needed. ACOG will update its members regarding any change to the regulatory status of 17-OHPC."