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Off-label drug use is associated with raised risk of adverse events, study finds

BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h5861 (Published 04 November 2015) Cite this as: BMJ 2015;351:h5861
  1. Michael McCarthy
  1. 1Seattle

The off-label use of prescription drugs was associated with a 44% increase in the risk of adverse drug events and an even greater risk, 54%, when the off-label use was not backed by strong scientific evidence, Canadian researchers have reported in a new study.1 Off-label prescribing is common, with one US study finding that about a fifth of doctors’ prescriptions were for off-label use.2

In the new study, researchers reviewed the primary medical records of a prospective cohort of more than 46 000 adult patients in Quebec who received around 150 000 new prescriptions and were tracked over six years from January 2005 to 2010. The researchers used the Canadian federal health department’s drug approval database to classify prescriptions as “on-label” or …

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