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# Panel Split on Makena’s Withdrawal After Failed Study
- URL: https://www.fdaweb.com/panel-split-on-makenas-withdrawal-after-failed-study/
- Published: 2019-10-30T12:00:00.000Z
- Updated: 2026-09-14T15:51:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145374

In a split vote, FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee has voted 9 to 7 to recommend that the agency remove from the market Amag Pharmaceuticals' accelerated-approval drug Makena (hydroxyprogesterone caproate injection) because a confirmatory trial failed to perform better than placebo to reduce the risk of preterm births in women with histories of singleton spontaneous preterm birth. The seven panel members voting to keep the drug on the market recommended that Amag conduct another confirmatory trial. Not surprisingly, panel members voted 16 to 0 that the confirmatory study failed to demonstrate the drug’s effectiveness.

In a statement after the meeting, Amag noted that “among the clinicians on the panel, five of the six who practice obstetrics voted to keep Makena on the market and generate more data. Amag agrees with several committee members who voiced concern that withdrawal of Makena would leave providers with no safe treatment options for pregnant women. The advisory committee’s recommendation, while not binding, will be considered by the FDA in making its decision.”

At the meeting, Public Citizen health researcher **Meena Aladdin** urged FDA to remove Makena from the market and prohibit pharmacy compounding of the medication because it is not effective. The advocacy group[ earlier this month](https://www.fdaweb.com/login.php?sa=v&aid=D5145188&searchWords=makena&cate=S&stid=%241%24kb3.dh%2F.%24R0eoPB3%2FPUGqNEWupg8LY0) filed a [petition](https://www.citizen.org/wp-content/uploads/2493.pdf?eType=EmailBlastContent&eId=c4360219-1abc-4c5c-9253-3a0d2b270821&ref=fdaweb.com) seeking to ban the drug. It said that when Makena gained accelerated approval in 2011 it was based largely on evidence from a single clinical trial that an advisory committee found did not adequately prove that the medication reduced the rate of fetal and neonatal health problems and death. The petition said an FDA statistical expert also opposed approval because data from the trial failed to provide convincing evidence that Makena was effective.  

Aladdin testified that maintaining approval of Makena in the absence of any clinical benefits being demonstrated by the two clinical trials would make a mockery of the more than 50-year FDA legal standard requiring substantial evidence of a drug’s effectiveness.