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FDA experts recommend withdrawing the only drug to prevent premature births due to doubts about its effectiveness

2022-10-19T16:07:18.636Z


Scientists advising the agency believe that Makena exposes women to "serious risks." Its manufacturer believes that its withdrawal may aggravate racial inequalities.


By Berkeley Lovelace Jr. -

NBC News

The advisory group of the Food and Drug Administration (FDA, for its acronym in English) approved this Wednesday to withdraw from the market a drug intended to prevent premature births, noting that its effectiveness is doubtful.

In a 14-1 vote, the recommendation from the federal agency's Obstetric, Reproductive and Urologic Drugs Advisory Committee closed a three-day meeting on clinical trials supporting Makena, the only drug approved in the United States to prevent childbirth. before term.

A pregnant woman during a check-up before giving birth. Felipe Dana / AP

The meeting included emotional testimony, including from advocates who said removing the drug could exacerbate racial disparities in maternal health.

The panel voted on three questions: whether the drug is effective, whether trial data support its approval, and whether it should stay on the market.

The panel voted no on each of the questions.

Source: telemundo

All news articles on 2022-10-19

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