<\/b><\/p>\n
<\/b><\/p>\n
WEDNESDAY, Oct. 19, 2022 (HealthDay News) — A U.S. Food and Drug Administration advisory committee on Wednesday voted to recommend that a controversial drug meant to prevent premature births be pulled from the market.<\/p>\n
FDA officials have said<\/a> they want to withdraw the medication, Makena, because of a lack of evidence that it works and due to its side effects. The drug was initially allowed as part of the agency’s accelerated approval program<\/a>, which lets a medication launch after promising early results while larger studies test it further.<\/p>\n But in a 14-1 vote for removal of the drug, the FDA Obstetrics, Reproductive, and Urologic Drugs Advisory Committee closed a three-day meeting on the evidence supporting Makena. It is the only drug approved in the United States to prevent preterm births.<\/p>\n “It would be unfair to keep the drug on the market and expose especially vulnerable populations to an ineffective therapy,” said panel member Mark Hudak, M.D., a pediatrician at the University of Florida College of Medicine in Jacksonville, NBC News<\/em> reported.<\/p>\n But some groups have defended the drug. “The need for an effective treatment for preterm birth<\/a> is great,” the American College of Obstetricians and Gynecologists says. “Makena and its associated generics represent the only treatment currently available to obstetrician-gynecologists to help prevent this condition.”<\/p>\n The panel’s vote does not mean the drug will be removed from the market, according to NBC News<\/em>. That decision is left to the FDA, which could make its final decision within a few months.<\/p>\n As presented during the hearing, we believe that Makena is effective in a higher-risk patient population, Raghav Chari, Ph.D., chief innovation officer at Covis, said in a press release<\/a>. We will work collaboratively with the FDA to clarify the next steps in this process. <\/p>\n