While controversy swirls around the abortion inducing drug mifepristone, the Food and Drug Administration pulled a different pregnancy-related medication off the market.
The Food and Drug Administration (FDA) pulled its approval of a drug meant to reduce the risk of preterm birth in pregnant women.
It cited a lack of effectiveness demonstrated by the treatment in trials.
The drug, Makena, was approved in 2011 under the FDA’s accelerated approval pathway. It worked as a synthetic form of progesterone, a necessary hormone required to maintain a pregnancy.
It was tentatively approved for pregnant women who already gave birth to one child and have a history of spontaneous preterm birth.
The administration stipulated that a separate study to confirm the manufacturer’s claims must be conducted following its approval.
Years later, that study failed to confirm the clinical benefits of Makena on preterm births.
The FDA’s Center for Drug Evaluation and Research first suggested the drug be removed in 2020. Covis Pharma, the maker of Makena, voluntarily withdrew the drug last month after regulators again recommended its removal.
It took four years of appeals before Covis agreed to withdraw its drug, highlighting the FDA’s limited power to remove a medication once give even conditional approval.
“While we stand by Makena’s favorable benefit-risk profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down,” said Raghav Chari, Covis’ chief information officer, in a statement.
“It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes—particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” FDA Commissioner Robert Califf said in a separate statement.
The FDA advised pregnant women currently taking Makena to speak with their doctors.
