FDA Says Makena Doesn't Prevent Premature Births, Seeks to Pull Drug From Market

But the FDA says existing data shows weekly injections of the drug don't help prevent a repeat preterm birth.

“Makena is being used as an example of the many different criticisms of this program,” said Rachel Sachs, a food and drug law specialist at Washington University of St. Louis. “That may not be fair to the other drugs, other diseases, other patients groups, but we're forced to respond to the situation it presents.”

The FDA approved Makena in 2011 based on a small study suggesting it reduced rates of premature birth in women with a history of early deliveries. Makena consists of a synthetic version of the hormone progesterone, which helps the uterus grow and maintain a pregnancy. Women can start the shots after 16 weeks of pregnancy.

But results from an international study of 1,700 women released in 2019 showed the drug neither reduced premature births — as originally thought — nor resulted in healthier outcomes for babies, while increasing the risk of blood clots, depression and other side effects in mothers.

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Company pushes back against FDA efforts to remove pregnancy drugA Food and Drug Administration meeting that opened Monday comes more than two years after the agency declared the drug Makena ineffective and called for its removal.
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FDA pushes to remove pregnancy drug, company pushes backThe 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.
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