FDA committee recommends withdrawing Makena for preterm birth prevention
An FDA advisory committee yesterday voted to recommend that Makena, a treatment to prevent women from having a preterm birth, be withdrawn from the market after a study found that it's ineffective, the Wall Street Journal reports.
Backdrop: The FDA approved the drug in 2011, but required a follow-up study. That study came out last week and found that the drug — which has become the standard treatment — doesn't decrease recurrent preterm births.
What they're saying: "At the end of the day we want to be giving pregnant women medications that work and help them and their babies," Adam Urato, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Mass., told the Journal. "This drug doesn't work."
Go deeper: When an expensive drug turns out to be a dud