Comparative treatment effects of on-label and off-label drug use: meta-epidemiological study

Lars G. Hemkens, Heiner C. Bucher

Status: completed Duration: Dec 2013 - Oct 2016

Off-label use of a drug refers to any application that is in deviation from the use approved by a drug licensing agency. Preferably off-label drug use should be considered when there is no alternative on-label treatment for a patient’s condition e.g. in case of serious conditions if approved drugs have failed. Off-label use is highly prevalent in medical practice but often not supported by good evidence. In this meta-epidemiological analysis the overall benefits and harms of off-label use is evaluated in comparison to licenced drugs used for the same indication.

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