Editing Off-label use (section)

{{Short description|Use of pharmaceuticals for conditions different from that for which they were approved}}'''Off-label use''' is the use of [[pharmaceutical drug]]s for an unapproved [[indication (medicine)|indication]] or in an unapproved age group, [[dose (biochemistry)|dosage]], or [[route of administration]].<ref name=nejm>{{cite journal |title=Regulating Off-Label Drug Use — Rethinking the Role of the FDA |author=Randall S. Stafford |journal=N Engl J Med |doi=10.1056/NEJMp0802107 |volume=358 |pages=1427–1429 |issue=14 |pmid=18385495 |year=2008|doi-access=free }}</ref> Both [[prescription drug]]s and [[over-the-counter drug]]s (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.

Off-label use is very common and generally legal unless it violates ethical guidelines or safety regulations. The ability to prescribe drugs for uses beyond the officially approved indications is commonly used to good effect by healthcare providers. For example, [[methotrexate]] is commonly used off-label because its immunomodulatory effects relieve various disorders.<ref name="pmid_21267732">{{Citation |last=Briem |first=S |display-authors=etal |year=2011 |title=[Current "off label use" of methotrexate for chronic inflammatory rheumatic diseases] |journal=Z Rheumatol |volume=70 |issue=2 |pages=123–128 |pmid=21267732 |doi=10.1007/s00393-010-0685-2 |postscript=.}}</ref> However, off-label use can entail health risks and differences in [[legal liability]]. [[Pharmaceutical marketing|Marketing of pharmaceuticals]] for off-label use is usually prohibited.