The FDA ordered Makena be pulled from pharmacies on Thursday, saying the drug had no benefit for pregnant women. The Food and Drug Administration on Thursday ordered the immediate withdrawal of the only drug meant to prevent preterm birth, saying it’s ineffective and risky for pregnant women. The FDA’s order comes more than two years after the agency first asked …
A federal advisory panel voted Wednesday to recommend that the only approved drug to prevent premature birth be removed from pharmacy shelves because studies have shown it does not work. The Times detailed in a February 2022 investigation how the drug’s maker — private equity-owned Covis Pharma of Luxembourg — and the companies that previously owned the rights to Makena …
Brittany Horsey of Baltimore says she was prescribed Makena during two pregnancies, yet both times the drug failed to work and the babies were born prematurely. The drug’s approval was based on a flawed government- Despite this questionable data and repeated concerns raised by one of its statisticians, the FDA approved the drug in 2011. The FDA says that it …
