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 …
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 …
