FDA Forces Unproven Premature Birth Drug Makena Off Market

By Matthew Perrone

On April 6, the U.S. Food and Drug Administration (FDA) ordered Makena, a drug used since 2011 to prevent premature births, to be removed from the market immediately. The order marks the first time the FDA forcibly removed a drug from the market after granting initial approval based on favorable early data. Makena, an injectable synthetic version of the hormone progesterone, was the only drug approved in the United States to address early birth risks in women with a history of preterm deliveries. The agency had been attempting to remove the drug from the market since a 2018 study found that it didn't lower premature birth rates or improve outcomes for infants. Swiss drugmaker Covis Pharma had continued to request additional time for further research but recently asked for a "winding down" period to allow patients to complete treatment before the drug's market withdrawal. That request was denied by the FDA, which said, "Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce."

Read more on the Associated Press.