FDA puts its foot down on Mak­e­na: New meta-analy­sis does not change call to pull the drug

A re­cent­ly pub­lished meta-analy­sis of 31 ran­dom­ized, con­trolled tri­als on the pre­ma­ture birth drug Mak­e­na is not chang­ing the FDA’s pre­vi­ous de­ci­sion to pull its ac­cel­er­at­ed ap­proval and re­move it from the mar­ket, the agency said late last week.

The FDA’s de­ci­sion to pub­licly cri­tique the meta-analy­sis is the lat­est twist in a saga that most re­cent­ly in­volved the FDA propos­ing to with­draw the ac­cel­er­at­ed ap­proval of Mak­e­na, al­most a decade since it first won ap­proval, af­ter a large, ran­dom­ized con­fir­ma­to­ry tri­al failed to show the drug’s ben­e­fit for new­borns or its abil­i­ty to re­duce the risk of pre-term birth.

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