Why AMAG’s drug should be pulled from shelves
Nearly 70 years ago, the world learned that DES, a hormone used by millions of pregnant women to prevent miscarriages and premature deliveries, didn’t actually work. But doctors kept prescribing it for another two decades, right up until the drug was linked to cases of cancer.
Today, in the case of AMAG Pharmaceuticals’ Makena, the FDA has a chance to implement the lessons of DES, according to one maternal-fetal medicine physician. Writing in STAT, Dr. Adam Urato points out that Makena, a hormone approved in 2011 to prevent premature births, was demonstrated to have no significant effect in a recent trial. The FDA is now considering whether to revoke that approval, and, in light of history, it should waste no time in doing so, according to Urato.
“History will judge us poorly if we do not pull Makena from the market and continue injecting this synthetic hormone into pregnant women,” Urato wrote.
Read more.
Today, in the case of AMAG Pharmaceuticals’ Makena, the FDA has a chance to implement the lessons of DES, according to one maternal-fetal medicine physician. Writing in STAT, Dr. Adam Urato points out that Makena, a hormone approved in 2011 to prevent premature births, was demonstrated to have no significant effect in a recent trial. The FDA is now considering whether to revoke that approval, and, in light of history, it should waste no time in doing so, according to Urato.
“History will judge us poorly if we do not pull Makena from the market and continue injecting this synthetic hormone into pregnant women,” Urato wrote.
Read more.
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