An FDA advisory panel recommended the agency remove Makena, a treatment for preventing preterm births, from the market after reviewing data that shows it may not be effective, according to STAT.
The panel voted 9-7 to remove AMAG Pharmaceuticals' drug, which was approved eight years ago and has since been the standard of care in treating premature birth in the U.S.
A study published in the American Journal of Perinatology found Makena failed to reduce recurrent premature births in women versus a placebo. The original 2003 study in which the approval was based on found a 30 percent decrease in premature births.
Additionally, a 2017 study in the American Journal of Obstetrics and Gynecology found Makena was ineffective and increased rates of gestational diabetes, according to STAT.
On Oct. 8, consumer advocacy group Public Citizen filed a citizen's petition asking the FDA to immediately withdraw Makena after it failed a confirmatory study.
Though the FDA is not required to follow the advisory panel's recommendation, the panel members unanimously agreed that the reviewed followup study failed to demonstrate that Makena was effective in reducing the risk of premature births in high-risk women.
The panel did note that the original study examined women from the U.S. with a high risk of premature birth, while the latest study involved women outside the U.S. with a lower risk of premature birth.
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