FDA granted accelerated approval for Makena in 2011 to address issue of preemies, but major study says drug doesn’t work
, published in 2019, showed no benefit. The preterm birth rate was not lower among those who received the shots, and their babies were not healthier – even as the shots put patients at risk of complications like blood clots and depression.
But a panel of independent advisers ultimately voted once again to remove Makena from the market – four years after the study showed no effect. When she became pregnant again, she received Makena injections, starting in the second trimester, until she was 37 weeks along.
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