FDA forces unproven premature birth drug Makena off market

The decision follows repeated efforts by Swiss drugmaker Covis Pharma to keep Makena on the U.S. market while it conducted additional studies. The medication was the only drug approved in the U.S. to help reduce the risk of early births in women with a history of preterm deliveries.

The injectable drug is a synthetic version of the hormone progesterone, which helps the uterus sustain pregnancy. 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 has been working to get the drug off the market since then, though Covis repeatedly appealed for more time to conduct further research.

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FDA forces unproven premature birth drug Makena off marketThe Food and Drug Administration is ordering an unproven drug intended to prevent premature births off the market
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FDA forces unproven premature birth drug Makena off marketThe Food and Drug Administration is ordering an unproven drug intended to prevent premature births off the market.
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