Off-label
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An off-label use of a drug means using an FDA-approved drug for an unapproved use. It is estimated that
Estimates are that 21% of all prescriptions are off-label, and an even higher percentage of 36.2% of medications in intensive care units are off-label.
As of September 25, 2022, a total of 2,719 decisions (2,250 federal) have referenced the term "off-label". Of those, only 231 decisions (196 federal) discuss the FDA in proximity with the "off-label" term, and many of those cases are class action product liability cases.