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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