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Petition: FDA Should Promptly Add Banned Medication to List of Withdrawn Drugs to Prevent Pharmacy Compounding

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should promptly add hydroxyprogesterone caproate, a drug for the prevention of preterm birth which was previously marketed under the brand name Makena, to its official list of drugs withdrawn or removed from the market because they were deemed unsafe or ineffective, Public Citizen said today in a petition to the agency. This move is necessary to prevent pharmacy compounding of this now-banned drug. Joining Public Citizen as a co-petitioner was Dr. Adam Urato, chief of Maternal-Fetal Medicine at the MetroWest Medical Center in Framingham, Massachusetts.

“To protect patients, the FDA must move swiftly to take regulatory action that would prohibit pharmacy compounding of the now banned hydroxyprogesterone for prevention of preterm birth,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “Without such action, the numerous obstetricians and fetal-medicine physicians who opposed the FDA’s proposal to withdraw approval of Makena likely will continue to prescribe compounded versions of this ineffective and potentially dangerous drug to pregnant women.”

The FDA withdrew approval of Makena and all related generic products on April 6 after concluding that the drugs are no longer shown to be effective and their benefits do not outweigh their risks when used to prevent preterm birth.

This action follows the nearly unanimous recommendation of the FDA’s Obstetrics, Reproductive, and Urologic Drugs Advisory Committee in October 2022 that the drug be withdrawn from the market. Public Citizen had petitioned the FDA in 2019 to ban the drug after a large post-approval clinical trial found that it is not effective for preventing preterm birth or major complications in newborn infants related to preterm birth.

“Importantly, FDA Commissioner Robert Califf and Chief Scientist Namandjé Bumpus themselves acknowledged in their final decision on the proposal to withdraw the approval of Makena that the current lack of adequate data supporting effectiveness of the drug implicates compounded products as well as Makena and its generic versions,” said Carome.