FDA Committee Recommends Removing Makena Drug For Preventing Premature Births

(RTTNews) - A U.S. Food and Drug Administration advisory committee recommended that a treatment for preventing premature births should be withdrawn from the market after reviewing a trial that indicated the medicine Makena is not effective.

Nine advisory committee members voted to recommend that the FDA pursue withdrawal of approval for Makena and seven committee members voted to leave the product on the market under accelerated approval and require a new confirmatory trial, AMAG Pharmaceuticals said in a statement.

AMAG said it agreed with several committee members who voiced concern that withdrawal of Makena would leave providers with no safe treatment options for pregnant women. The advisory committee's recommendation, while not binding, will be considered by the FDA in making its decision.

The FDA approved the treatment in 2011, contingent upon completing a follow-up study.