Off-label prescriptions: patient safety first

Abstract

Use of off-label cancer drugs is a common, yet controversial, practice. In 2009, guidelines published by the American Society of Clinical Oncology suggested men at high risk of prostate cancer might benefit from the off-label use of 5α-reductase inhibitors (5-ARIs) to reduce cancer risk. However, an increased risk of high-grade cancer, particularly with finasteride, was also noted. Despite these results, in 2010, GlaxoSmithKline applied to the US Food and Drug Administration (FDA) asking for a label change for another 5-ARI, dutasteride, to decrease the incidence of prostate cancer in men at high risk.