FDA advisors recommend yanking approval of preterm birth prevention drug after it flops in crucial study - (The Philadelphia Inquirer via NewsPoints Desk)

  • An FDA advisory panel narrowly voted on Tuesday to recommend that Amag Pharmaceuticals' Makena, a synthetic version of the hormone progesterone, and the only drug approved to prevent preterm birth, be pulled the market, reported The Philadelphia Inquirer.

  • According to results from a just-published clinical trial that had been ordered by the US regulator as a condition of approval in 2011, Makena was no better than placebo at preventing premature birth or reducing the resulting problems.

  • Before the hearing, the American College of Obstetricians and Gynecologists said it had reviewed Amag's results and was not changing its guidance. 

  • However, the Society of Maternal-Fetal Medicine released new guidelines suggesting that doctors assess the patient's level of risk before recommending hydroxyprogesterone injections.

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