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FDA decision on preterm birth drug’s withdrawal nears, putting spotlight on patients, agency

March 6, 2023


Nicole’s first child was born two months early. Pregnant with her second and fearing another preterm labor, she learned of a hormonal shot that could lower her risk.

“After I had my first baby, even the people in the [neonatal] ICU, they kept telling me, ‘If you ever have another baby, you’re going to have to be on shots,’” Nicole said.

Nicole’s doctors told her the drug, called Makena, was her only option to prevent preterm labor, which is associated with a higher risk of death and disability for the baby. But none mentioned its approval was conditional, and that its effectiveness was in question.

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