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Preterm births: US panel recommends withdrawal of prevention drug in controversial vote

BMJ 2019; 367 doi: (Published 06 November 2019) Cite this as: BMJ 2019;367:l6391
  1. Elisabeth Mahase
  1. The BMJ

An independent advisory panel to the US Food and Drug Administration has recommended that approval should be removed for Makena (hydroxyprogesterone caproate), a drug used in the US to prevent preterm birth, because of a lack of evidence that it works.

In a meeting on 29 October the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee voted by nine to seven to withdraw approval for the drug. But the American College of Obstetricians and Gynecologists has warned that removing the drug from the market could be a mistake, and its manufacturer has claimed that five of the six obstetricians on the committee voted to keep Makena on the market.

The FDA is not bound by the committee’s decision and will conduct its own review of the committee’s feedback before making a final decision. However, the agency typically follows …

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