WASHINGTON — Federal health advisers have concluded that a drug intended to prevent premature births hasn’t been shown to work, clearing the way for U.S. regulators to follow through on a long-delayed effort to get it off the market. The Food and Drug Administration’s advisory panel voted 14-1 Wednesday that the injectable drug Makena should be withdrawn, despite appeals from …
During her pregnancies, doctors encouraged Brittany Horsey to take a preterm birth drug called Makena. “In the vast majority of accelerated approvals,” it said, the drug’s clinical benefits were later verified through the confirmatory studies it required. Exondys 51 Duchenne muscular dystrophy $300,000 per year Aduhelm Alzheimer’s disease $28,200 per year Makena Preterm birth $13,000 per pregnancy For decades, the …
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 …
