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Petition to the FDA to Ban the Drug Hydroxyprogesterone Caproate (Makena), Approved for Prevention of Preterm Birth

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Public Citizen petitioned the Food and Drug Administration (FDA) to immediately withdraw approval of the widely prescribed drug hydroxyprogesterone caproate (sold under the brand name Makena) and to place this drug on the list of drug products that may not be used in pharmacy compounding. These actions were requested because the results of a recently completed post-market clinical trial showed that it is not effective for preventing preterm birth prior to 35 weeks of pregnancy or major fetal and neonatal complications related to preterm birth.

October 8, 2019, FDA acknowledgment letter.

April 3, 2020, FDA interim response letter.

October 5, 2020, FDA response letter.

See Public Citizen’s other work on hydroxyprogesterone caproate (Makena).