Opinion: The FDA must pull Makena off the market
Should doctors be able to prescribe and use a drug that doesn’t work, and may cause harm? That’s the question currently in front of the FDA as it decides what to do about a drug called Makena.
The FDA approved 17-hydroxyprogesterone caproate (Makena) in 2011 as a way to prevent preterm birth in women with a prior spontaneous preterm birth. The drug got the green light through the FDA’s accelerated approval pathway, which is reserved for drugs that treat a serious or life-threatening disease or condition.
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