period of several months so that women taking the drug could complete their treatment. The FDA rejected that and said Thursday that the action against Makena and several generic versions should take effect immediately.
It can cause side effects, including blood clots, depression and allergic reactions. Given those risks, FDA staffers previously concluded there was no upside to keeping the drug available, given its lack of confirmed benefit. The FDA expedited Makena’s approval in 2011 based on a small study suggesting it reduced rates of premature birth in women who had previously had trouble bringing a pregnancy to term. But results from a 1,700-participant study completed in late 2018 showed the drug neither reduced premature births — as originally thought — nor resulted in healthier outcomes for babies.
“It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes,” Califf said in a statement Thursday. Women who have a current prescription for the drug should direct any questions to their doctor, the agency said.
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