What should I know about progesterone shots and preterm birth?

Progesterone shots used to be recommended to help prevent preterm birth. These shots are known by the brand name Makena and by the generic name 17-OHPC (17-alpha hydroxyprogesterone caproate).

In April 2023, the U.S. Food and Drug Administration (FDA) said that progesterone shots should no longer be used to prevent preterm birth. The FDA withdrew Makena and all generic versions of the medication from the market.

The FDA made this decision because studies showed that the shots may not be effective for everyone. Makena had been approved for anyone who had a prior preterm birth with a single baby. It is possible that Makena may be effective for a smaller group of people. More research is needed on this.

If you are in the middle of receiving progesterone shots, you can talk with your doctor about whether to continue. There are no concerns about the safety of the shots. But the medication will now be in limited supply and will soon be unavailable.

It is possible that some doctors may still prescribe progesterone shots using compounding pharmacies. Compounding pharmacies make custom medications, called compounded medications. These medications are not regulated by the FDA. They may vary in strength and purity. That means you can take too little or too much without knowing it. Your state may limit access to compounded medications, and they may not be covered by insurance.

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This information is designed as an educational aid for the public. It offers current information and opinions related to health care. It is not intended as a statement of the standard of care. It does not explain all of the proper treatments or methods of care. It is not a substitute for the advice of a physician. Read ACOG’s complete disclaimer.