FDA Revokes Approval of Makena, the Only Drug That Reduces Premature Births
The Food and Drug Administration (FDA) has ordered the immediate withdrawal of Makena, a drug intended to prevent premature births, which has been available for years despite evidence showing it doesn’t help pregnant women. Makena, a synthetic version of the hormone progesterone, was the only drug approved in the US to reduce the risk of early births in women with a history of preterm deliveries. FDA Asks for An Immediate Action Swiss drugmaker Covis Pharma had been trying to keep the drug on the US market while it conducted additional studies. However, the FDA rejected Covis’ proposal of a “winding down” period and said that the action against Makena and several generic versions should take effect immediately. The FDA expedited Makena’s approval in 2011 based on a small study that suggested it reduced rates of premature birth in women who had previously had trouble bringing a pregnancy to term. However, results from a 1,700-participant study completed in late 2018 showed the dru...