
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. “Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved,” Califf added. The decision follows a meeting of one of the agency’s advisory committees last October where panel members voted 14-1 to recommend that Makena be pulled from the market. FDA officials have long said they want to withdraw the medication because of lack of evidence that it works and its side effects. “It would be unfair to keep the drug on the market and expose especially vulnerable populations to an ineffective therapy,” panel member Dr. Mark Hudak, a pediatrician at… read on > read on >