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As an Oct. 29 regulatory meeting nears to review the Makena treatment for preventing premature births, a consumer advocacy group is urging the Food and Drug Administration to immediately withdraw the controversial drug because it failed a confirmatory study.

In a citizen’s petition being filed with the FDA on Tuesday, Public Citizen pointed to a required followup effectiveness study that was released in March, showing Makena is no better than a placebo in preventing preterm birth or major complications from preterm birth. The advocacy group also argued the agency erred when it endorsed the medicine in 2011 under the accelerated approval program, because data from a Phase 3 study that largely formed the basis for approval was “seriously flawed.”

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  • Furthermore, hydroxyprogesterone, even if it has anti-inflammatory properties, fails to address the underlying cause of the inflammation associated with preterm births which is why it must be administered each week.

  • It is useful to know about this, but please, STAT, indicate the real name of the drug in the story (hydroxyprogesterone) instead of using yet another cute made up trade name. We have known for a very long time that progestogens do not provide benefit in early pregnancy. Using new names allows companies to pretend they have a new drug, and invent new stories about it.

    • Hi James Dickinson,

      Thanks for the note and you make a fair point. Although I generally refer to medicines by their trade names, there are times when the chemical name can be useful to know – and you offer a good explanation in this case.

      So going forward, I will keep that in mind.

      ed at pharmalot

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