PREMATURITY PREVENTION (PROGESTERONE)
PROJECT
FDA Withdraws Approval for Makena and Updates its Practice Advisory
The American College of Obstetrics and Gynecology updated its Practice Advisory to address the April 6, 2023, decision by the U.S. Food and Drug Administration (FDA) to withdraw approval of Makena and its generics (17-alpha hydroxyprogesterone caproate [17-OHPC]). This Practice Advisory serves to update the current evidence and recommendations for the use of progesterone for the prevention of recurrent preterm birth.
ACOG’s Practice Advisory indicates that Vaginal progesterone may be considered as a treatment option for patients with a history of preterm birth, singleton gestation, and a shortened cervix.
Preterm birth is the number one cause of newborn death in Ohio. The OPQC Progesterone Project's goal was to decrease premature births in Ohio before 32 weeks From 2017-2018; OPQC tested strategies for implementing this intervention with 23 Obstetrics outpatient clinics that were identified by OPQC’s 20 Charter OB sites.
*(ACOG = American College of Obstetricians & Gynecologists)
Publications
A Statewide Progestogen Promotion Program in Ohio. Iams JD, Applegate MS, Marcotte MP, Rome M, Krew MA, Bailit JL, Kaplan HC, Poteet J, Nance M, McKenna DS, Walker HC, Nobbe J, Prasad L, Macaluso M, Lannon C. Obstet Gynecol. 2017 Feb;129(2):337-346. doi: 10.1097/AOG.0000000000001841. PMID: 28079774
Resources
Resources are currently being updated to address the removal of Makena. Please check again soon.
The OPQC Progesterone Project was funded by the Ohio Department of Health and the Medicaid Technical Assistance and Policy Program (MEDTAPP), and administered by The Ohio Colleges of Medicine Government Resource Center. The views expressed in this presentation are solely those of the authors and do not represent the views of state or federal Medicaid programs. This study includes data provided by the Ohio Department of Health which should not be considered an endorsement of this study or its conclusions .