Makena is a progestin injection used to reduce the risk of preterm birth, or birth before 37 weeks of pregnancy, in pregnant people with a history of spontaneous preterm birth. Policymakers and health advocates, including the NWHN, are advocating to have Makena taken off the market because there is no evidence showing that Makena is effective in preventing preterm birth. This month, the FDA’s Center for Drug Evaluation and Research agreed with our recommendation and officially proposed that Makena be withdrawn from the market.

Nearly 10 percent of babies born in the United States are premature, making preterm birth the nation’s leading cause of infant mortality and disability. Makena was created in 2011 with its main ingredient —  synthetic hormone 17-hydroxyprogesterone caproate, or “17P” — highly desired by obstetricians whose pregnant patients are at risk for preterm birth. Up until Makena entered the market in 2011, compounding pharmacies distributed low-cost injections of 17P for use by pregnant women. A weekly dose of the compounded drug totaled, at maximum, $20. Makena, on the other hand, costs $1,500 for the same dose; approximately 100 times more than the original. What’s more, a study conducted by Harvard University found no conclusive difference between the results in women who took Makena and women who took the original compounded 17P. 

In 2016, the FDA ended the compounding of 17P by giving AMAG Pharmaceuticals, the makers of Makena, the exclusive rights to manufacture the drug. Makena became the only medication currently approved to prevent preterm birth. Yet, even though Makena was approved by the FDA, it doesn’t mean it works. 

Makena was given accelerated approval by the FDA, a right reserved for drugs designed to treat serious or life-threatening diseases or conditions. But as a condition of approval, the company was required to perform follow up trials to show clinical benefit, such as improved outcomes for the babies whose mother had received it. The makers of Makena took eight years to conduct a confirmatory trial in 2019, which showed no such benefit. Not only that, multiple clinical trials have failed to demonstrate that Makena and 17P actually work in preventing preterm birth. In fact, the trials found that Makena actually increased the preterm birth rate among high-risk pregnant women. However, until the manufacturers of Makena decide to remove the drug from the market, or the FDA commissioner forces the drug’s removal, Makena remains available for physicians to prescribe. The FDA commissioner will determine whether to withdraw Makena from the market if AMAG Pharmaceuticals requests a hearing. The NWHN endorses the removal of Makena from the market. Because no drug is completely safe or free from side effects, pregnant people deserve medication that has been proven to work.

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