US mothers face uncertainty as lone, unproven drug for preterm birth pulled

FDA granted accelerated approval for Makena in 2011 to address issue of preemies, but major study says drug doesn't work

Makena is the only drug approved specifically to prevent premature birth, a major health issue facing children and families, in the US. In the 12 years since it was fast-tracked by the US Food and Drug Administration (FDA), hundreds of thousands of patients in America have received injections of Makena, which is about 5,200% more expensive than generic versions of the same medication.

There was just one problem: there's no evidence Makena actually works.