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.
That certainly applies to preterm birth — birth before 37 weeks of pregnancy — which is a major problem in, and the rate has been rising. Babies born too early, especially before 32 weeks, are at increased risk of dying, and those who live are at increased risk of developing health issues and long-term problems.
