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Cytotec Induction And Off-Label Use

by Marsden Wagner | August 31, 2003

Editor’s note: This article first appeared in Midwifery Today, Issue 67, Autumn 2003.Join Midwifery Today Online Membership Without adequate testing of Cytotec (misoprostol) for labor induction, obstetricians simply began to use it on their birthing women. They were taking advantage of a huge loophole in our drug regulatory system. Once a drug is approved by the FDA for a specific medical indication and put on the market, there is absolutely nothing to prevent any doctor from using that drug for any indication, in any dose, for any patient he or she chooses. Since the label of the drug contains the indications approved by the FDA, this is called “off-label” use of a drug. When obstetricians using Cytotec induction are confronted about their willingness to use a drug “off-label,” they inevitably answer: “We use drugs off-label all the time.” There are several serious problems with this answer. First, in reality, using Cytotec for induction is not “off-label” at all—it is “on-label contraindicated.” On the Cytotec label it is explicitly written that this drug is contraindicated for use on pregnant women. Contraindication would not be on the label unless data exist suggesting possible serious risks from such use. “On-label contraindicated” is a whole different level of risk-taking than a use that is not mentioned one way or the other on the label. A second reason to be concerned with the offhand answer of some obstetricians is that all off-label use is lumped together as though there were equal risks involved. During a case I was involved in, I asked the obstetrician about the off-label use of Cytotec for labor induction. He replied with the same answer that I have heard from so many clinicians: “We use Cytotec off-label for induction just like we use other drugs off-label all the time.” Compare this… Read more…. Cytotec Induction And Off-Label Use