Our study provided an estimate of the frequency of off-label drug use, situations when medications are prescribed for clinical indications not approved by the US Food and Drug Administration. We estimated that 21% of all drug uses in the United States are for off-label indications. Although this is an accepted part of medical practice often benefiting patients, far less scientific evidence is generally available to support off-label prescribing. As our article highlighted, 73% of off-label uses lacked strong scientific evidence.
Stafford RS, Radley DC, Finkelstein SN. Positive Outcomes Through the Appropriate Use of Off-Label Prescribing—Reply. Arch Intern Med. 2006;166(22):2554-2555. doi:10.1001/archinte.166.22.2555