A committee for the US Food and Drug Administration now recommends that the approval of Makena, a drug used to reduce the risk of preterm births, should be withdrawn — and some women who have used the medication are sounding the alarm
A committee for the US Food and Drug Administration now recommends that the approval of Makena, a drug used to reduce the risk of preterm births, should be withdrawn -- and some women who have used the medication are sounding the alarm.
Blood tests to predict preterm birth risk raise excitement -- and questionsThe 9-7 vote, which took place at a meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee on Tuesday, came in response to evidence suggesting that the drug was not effective.The committee serves as an advisory group to the FDA and the voting results are not binding, said Dr.
The medication now remains in limbo until the FDA makes a final decision based on its committee's new recommendations."I predict FDA will remove the drug from the market, since the confirmatory trial showed no benefit, and removing the drug does not necessarily completely eliminate the opportunity for some women to receive the therapy," Gellad said."There is an 80% chance I will be right.
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