Response to the Food and Drug Administration’s withdrawal of 17-alpha hydroxyprogesterone caproate

Publications & Guidelines, SMFM Statement,

On April 5, 2023, the US Food and Drug Administration (FDA) withdrew approval of 17-alpha hydroxyprogesterone caproate (17-OHPC), effective immediately, due to lack of evidence that it reduces the risk of recurrent spontaneous preterm birth (PTB). This decision withdraws approval for all formulations of 17-OHPC (both intramuscular and subcutaneous) and applies to both brand name (Makena) and generic versions of the medication. We agree with the FDA determination and discourage continued prescribing of 17-OHPC, including through compounding pharmacies. We do not recommend changing indications for cerclage, indications for vaginal progesterone in patients with short cervix, or recommendations against activity restriction based on the FDA withdrawal of 17-OHPC from the market. We recommend that discussion of the use of vaginal progesterone for primary prevention of recurrent PTB without input of cervical length or in those with a cervical length of 25 mm or greater include a shared decision-making process, especially if a progesterone formulation for PTB prevention was received in a prior pregnancy. The FDA determined that it would be inappropriate to delay the effective date of the withdrawal to allow patients currently receiving 17-OHPC to finish treatment. We agree with the FDA that there is no evidence of benefit with continued treatment. Patients currently receiving 17-OHPC can be counseled that the FDA’s Center for Drug Evaluation and Research (CDER) has not identified evidence of harm from discontinuation prior to 37 weeks of gestation.

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TAGS: 17-alpha-hydroxy-progesterone caproate, cerclage, preterm birth, prior ptb, progestrogens, prior preterm birth, care of high-risk pregnancy