Only Drug to Prevent Premature Births Will Be Pulled from U.S. Market

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The maker of the only drug approved to reduce the risk of premature labor in the U.S. wants to pull it off the market

he maker of the only drug approved to reduce the risk of premature labor in the U.S. wants to pull it off the market—gradually—years after research raised questions about how well it works.in an orderly fashion after a U.S. Food and Drug Administration advisory panel recommended retracting its approval at a meeting in October. While the medicine had won accelerated approval in 2011, a subsequent study intended to confirm its benefits found it didn’t work better than older drugs.

The situation is adding to the controversy around expedited approvals in the U.S., which allow experimental drugs to be given to patients based on preliminary data that suggests they will have a significant benefit. The follow up research required to validate those expectations is often delayed, studies show, meaning patients are at risk of being exposed to questionable treatments for years.

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شكرًا لك على تعليقك. سيتم نشر تعليقك بعد مراجعته.

One of the old drugs was terbutiline!

Boorish and Hooligans join forces to bring chaos. Be wise and count your chickens before they hatch.

Okay So my oldest daughter born April 10th my younger daughter December 10th my granddaughter March 0th my sons due date was October 10th So they gave me a pill to prevent early labor pains my son did not come till 5 days later you tell me if they're messing with Mothernature

You can't possibly raise a good child if you were not to know whose child to bear.

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