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Medicine Approved to Treat Preterm Birth Is Taken off the Market

Published August 23, 2023

In April 2023, the US Food and Drug administration (FDA) announced its decision to withdraw the only approved medicine used to prevent preterm birth from the market. Makena (hydroxyprogesterone caproate) was approved by the FDA in 2011 to reduce the risk of preterm birth in women who are pregnant with one baby and have a history of preterm birth. Hydroxyprogesterone caproate is a man-made form of the body’s naturally occurring hormone progesterone.

In 2011, FDA granted permission to use this medicine to treat preterm birth under a special process known as an accelerated approval. This type of approval may be used if a drug company provides evidence of a promising treatment for which there are no other available options. In 2003, a small study concluded that if Makena was given once a week to a pregnant woman with a history of preterm birth, it may reduce the risk of preterm birth. However, according to the FDA’s accelerated approval process, at a later date, the company must provide evidence that the medicine is both safe and effective to treat the intended condition (preterm birth).  

In 2019, a second study was conducted but failed to show that Makena reduced the risk of preterm birth. As a result, FDA attempted to withdraw the approval of Makena (and all generic forms of hydroxyprogesterone caproate) for use in treating preterm birth. The manufacturer, however, appealed this decision until the spring of 2023.

There are currently no other FDA-approved medicines to prevent or treat preterm birth. As a result, some doctors may continue to prescribe hydroxyprogesterone caproate. While it would not be available from a regular pharmacy, a compounding pharmacy (a pharmacy that makes medicine using raw ingredients) may still dispense it.

Here’s what you can do: If you are at risk for preterm birth, you should be monitored closely by your doctor. If your doctor prescribes hydroxyprogesterone caproate to prevent preterm birth, know that this medicine is no longer approved by the FDA and should not be used. Hydroxyprogesterone caproate that may still be available from compounding pharmacies is not evaluated for quality, safety, and effectiveness by the FDA and should not be used to treat preterm birth.

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