FDA Pulls Pregnancy Drug Makena From the Market

Officials say the treatment—meant to prevent preterm births— didn't work as intended and the risks of taking Makena outweighed the potential benefits.

Premature baby holding parent's finter

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The Food and Drug Administration (FDA) has pulled the only medication intended to help prevent premature births. The problem? Officials say it not only didn't work, but the risks of taking the medication outweighed any potential benefits.

The FDA made the move to pull the drug, Makena, and its generic forms months after an advisory committee made the recommendation. The FDA's Obstetrics, Reproductive, and Urologic Drugs Advisory Committee held a hearing and listened to testimony about the medication and studies surrounding it.

“It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes—particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” FDA Commissioner Robert M. Califf, M.D. says in a news release. “Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved.”

Just about a month before the FDA's decision, drugmaker Covis Pharma announced it "respects" the recommendation of the FDA panel. Covis had set out to voluntarily pull Makena and begin a "wind-down period" for those who were currently being treated. The FDA rejected that plan, saying the withdrawal needed to happen immediately.

Preterm Births

  • 1 in 10 American births is premature, which is defined as a live birth before 37 weeks of gestation.
  • Not all birthing groups experience the same rate of premature births. For example, in 2021, Black pregnant people had a preterm birth rate of 14.8% compared to Hispanic (10.2%) and White (9.5%).
  • Some common causes of preterm birth include smoking, substance abuse, expecting multiples, and a short time period between pregnancies. But even if these risk factors are not present, a pregnant person can still experience a spontaneous preterm birth.

What Is Makena and Why Was it Pulled?

Makena is an injectable drug given to a pregnant person weekly between 16 and 36 weeks with the goal of reducing the risk of preterm births in pregnant people with one baby, and a history of preterm birth.

It was fast-tracked through the approval process in 2011 by the Center for Drug Evaluation and Research (CDER), an arm of the FDA. The process was accelerated because of the need for such a treatment—and at the time it was thought to provide some advantages to other treatments.

The fast-tracked approval was based on a study in 2011. It showed promise and suggested Makena reduced preterm labor in people who had a previous unexplained preterm birth. But as a condition of the approval, the drugmaker Covis Pharma had to continue clinical trials.

However, in the company's latest trial, Makena's effectiveness was lower than expected. In fact, it didn't really demonstrate the drug's effectiveness to reduce preterm birth at all. The drug also didn't show any improvement in the overall health of the babies born to parents treated with Makena.

What Should I Do If I'm Being Treated With Makena?

Since Makena is no longer approved by the FDA, it is now illegal and should not be distributed. If you are currently being treated with Makena, make sure you contact the health care provider who prescribed it for you about any next steps you should take.

The FDA does recognize there is some supply left in the market, including at physicians' offices and pharmacies. Officials recommend health care providers no longer prescribe or administer whatever supply they have left.

Preventing Pre-term Births

With the FDA pulling Makena from the market, there are now no medications that can help prevent preterm births. Until science can solve the mystery of why some births are preterm or how to create effective prevention measures, the best way to lower the risk of preterm labor is to have preventative screenings while pregnant if access to affordable health care is an option. That includes screening and treating for vaginitis, sexually transmitted infections, urinary tract infections, and other infections that can damage the health of an unborn baby.

It's important to note that access to prenatal care is much harder for marginalized people. Black and Latinx communities face higher barriers to care than other groups.

“We acknowledge at the outset the serious problems of preterm birth with respect to both maternal and neonatal health and the contribution of institutional forces that have led to health disparities, including preterm birth, among Black women,” says FDA chief scientist Namandjé Bumpus, Ph.D. in the news release. “Nothing in this opinion is intended to minimize these concerns—to the contrary, our hope is that this decision will help galvanize further research.”

Pregnancy can be messy, beautiful, exciting, and nerve-racking for anyone going through it. But having to worry about the efficacy of a drug meant to prevent something terrible from happening shouldn't be a burden any patient should carry. Talk to your doctor about prescriptions, procedures, and lifestyle habits to make sure that you feel confident about the health care that you receive.

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  1. Preterm Birth. Centers for Disease Control and Prevention. 2022.

  2. Makena (hydroxyprogesterone caproate injection) Information. U.S. Food and Drug Administration. 2023.

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