Hydroxyprogesterone caproate
Brand name: Makena
Public Citizen has been assessing the quality and efficacy of drugs and devices since its founding in 1971. We use the law, petitions, and letters to monitor the FDA and coax the agency into action. Our actions have contributed to many drugs being pulled off the market. Public Citizen has also been instrumental in getting “black box” and other warnings on drugs. Our advocacy work on this drug is available below.
If you are interesting in reading our evaluations of the safety and efficacy of medications as well as information on drug side effects and interactions, please visit WorstPills.org.
More information on hydroxyprogesterone caproate (Makena)
- Ineffective Medication for Prevention of Preterm Birth Should Have Been Withdrawn Years Ago, March 8, 2023
- Follow-up Comments to the FDA Regarding CDER’s Proposal to Withdraw Approval of Makena (Hydroxyprogesterone Caproate), November 2, 2022
- Press Statement: FDA Commissioner, Chief Scientist Must Move Swiftly to Remove Medication for Prevention of Preterm Birth from Market, October 19, 2022
- Testimony Before the FDA’s Hearing on CDER’s Proposal to Withdraw Approval of Makena (Hydroxyprogesterone Caproate), October 18, 2022
- Letter to the FDA Urging That the Composition of the Advisory Committee for the Upcoming Hearing on the Proposal to Withdraw Approval of Hydroxyprogesterone (Makena) Be Fairly Balanced, October 27, 2021
- Testimony Before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee Regarding Hydroxyprogesterone Caproate (Makena), October 29, 2019
- Petition to the FDA to Ban the Drug Hydroxyprogesterone Caproate (Makena), Approved for Prevention of Preterm Birth, October 8, 2019