In Oct 2019, a Food and Drug Administration advisory committee recommended that approval be withdrawn for Makena – 17-α-hydroxyprogesterone caproate or “17P.” In Oct 2020, the FDA’s Center for Drug Evaluation and Research issued the recommendation that Makena and its generic equivalents be pulled from the market. There has not yet been a final decision, and Makena and generic 17P remain on the market. Both the American College of Obstetrics and Gynecology and the Society for Maternal-Fetal Medicine have issued statements recommending no changes to the existing clinical guidance regarding 17P. As recommended earlier, providers should engage in a framework of shared decision-making with at-risk patients to decide whether or not to use 17P. Please see this handout for more information.
Click HERE to read new guidance from the Society for Maternal-Fetal Medicine (SMFM) regarding vaginal progesterone or 17P for preterm birth prevention.
Key take-away from new guidance:
Although the results of this study suggest that either 17-OHPC or vaginal progesterone appear to offer a benefit to women with a singleton gestation and either short cervix or prior sPTB, the certainty regarding the benefit, both maternal and neonatal, is greatest for vaginal progesterone.
Questions? Email Erin McClain.