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 …
WASHINGTON — The maker of the only U.S. drug intended to prevent premature births is making a last-ditch effort this week to keep its medication on the market, even as health regulators insist that it doesn’t work. “Makena and its associated generics represent the only treatment currently available to obstetrician-gynecologists to help prevent this condition.” But the FDA says existing …
Brittany Horsey of Baltimore was prescribed the drug Makena during two of her pregnancies because doctors believed she was at risk of giving birth too soon. “We keep injecting pregnant women with a synthetic hormone that hasn’t been shown to work,” said Adam Urato, chief of maternal and fetal medicine at MetroWest Medical Center in Framingham, Mass. The company said …
