The U.S. Food and Drug Administration on Thursday formally withdrew its approval of a drug that was meant to prevent preterm births.
Sold as Makena, the drug was first approved in 2011 under the FDA’s accelerated approval program, but subsequent research questioned the medication’s effectiveness and noted serious side effects that included blood clots and depression.
“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 Dr. Robert Califf said in an agency news release.
