Details
The FDA initiated this analysis to better understand utilization of hydroxyprogesterone caproate (HPC) injection, including Makena® and its generics, among pregnant women in the United States. We identified 3,445,739 live-birth pregnancies (among 2.9 million women) between 2008 and 2018 in the Sentinel Distributed Database (SDD). Of these pregnancies, 6.5 per 1,000 pregnancies used injectable HPC, showing modest use of injectable HPC during the second and/or third trimesters among all live-birth pregnancies in the SDD. The majority (73%) of pregnancies with injectable HPC use had at least one of three obstetrical indications of interest recorded before or during the pregnancy.
Sentinel analysis results were presented at an FDA Advisory Committee for consideration in assessing the potential public health impact of withdrawing Makena’s accelerated drug approval. Following the FDA Advisory Committee, the FDA’s Center for Drug Evaluation and Research (CDER) recommended withdrawing Makena’s accelerated approval. FDA withdrew approval of Makena on April 6, 2023, because the confirmatory trial failed to verify the clinical benefit of Makena nor did the trial show that Makena reduced the risk of preterm birth.