Use of Progesterone for the Prevention of Recurrent Preterm Birth
Frequently Asked Questions
Frequently Asked Questions
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Last updated April 7, 2023 at 4:07 p.m. EST.
Patients currently receiving treatment should talk to their obstetric care professional about continuing treatment. The U.S. Food and Drug Administration (FDA) withdrew approval of Makena and its generics because its assessment was that these drugs are no longer shown to be effective for patients with a prior preterm birth (FDA 2023). The FDA’s decision to withdraw approval does not appear to be based on safety concerns about Makena and its generics. The FDA’s Center for Drug Evaluation and Research (CDER) has not identified harm from discontinuation prior to 37 weeks of gestation; therefore, it is reasonable to stop treatment prior to completion of the progesterone course (FDA CDER 2022). However, patients may also choose to complete their progesterone course after a shared decision-making discussion with their obstetric care professional. There are limited supplies of these drugs available.
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Last updated April 7, 2023 at 4:07 p.m. EST.
While the FDA has withdrawn the approval of Makena and its generics, there is a limited supply of these drugs that has already been distributed, including to health care professionals’ offices and pharmacies. The FDA acknowledges that some obstetric care professionals might continue to prescribe or administer that limited remaining supply to their patients. However, it is recommended that obstetric care professionals consider the FDA’s conclusion that these drugs are not shown to be effective for the indication for which they were approved and do not have benefits that outweigh their risks to patients. New prescriptions of Makena outside of the current available limited supply will not be able to be filled.
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Last updated April 7, 2023 at 4:07 p.m. EST.
Although compounding remains an option, the FDA’s decision to withdraw approval of Makena will significantly impact access to and availability of 17-alpha hydroxyprogesterone caproate (17-OHPC) for the prevention of preterm birth. Drug products containing hydroxyprogesterone caproate, the active ingredient in Makena, may be compounded under certain sections of the Federal Food, Drug, and Cosmetic Act if the conditions described in those sections are met (FDA 2023).
Compounded drugs, including those containing hydroxyprogesterone caproate, do not undergo FDA premarket review for safety, effectiveness, or quality. Regulatory concerns in some states or potential limited coverage by medical insurance carriers may result in limited access to compounded medications in some regions of the country.
Access ACOG’s Practice Advisory “Updated Clinical Guidance for the Use of Progesterone Supplementation for the Prevention of Recurrent Preterm Birth.”
Please contact [email protected] with any questions.
This document has been developed to respond to some of the questions facing clinicians providing care for patients with a previous preterm birth. As the situation evolves, this document may be updated or supplemented to incorporate new data and relevant information. This information is designed as an educational resource to aid clinicians in providing obstetric and gynecologic care, and use of this information is voluntary. This information should not be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. It is not intended to substitute for the independent professional judgment of the treating clinician. Variations in practice may be warranted when, in the reasonable judgment of the treating clinician, such course of action is indicated by the condition of the patient, limitations of available resources, or advances in knowledge or technology. The American College of Obstetricians and Gynecologists reviews its publications regularly; however, its publications may not reflect the most recent evidence. Any updates to this document can be found on acog.org or by calling the ACOG Resource Center.
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