Older Medicines with Modern Alternative Uses
Many medicines, new and old, are prescribed to patients for a use that is not listed on the drug’s label. This is referred to “off-label” use and it is a common occurrence in medical and psychiatric settings. In fact, the off-label use of many medicines can be very advantageous to the patient.1
80-90 Percent of Patients Prescribed Off-Label Medicines
After the FDA approves a medicine for a certain use, they no longer have control over how the medicine is prescribed. According to the United States General Accounting Office, 33 percent of cancer medicines have been prescribed off-label. Another study found that 81 percent of AIDS patients had received at least one off-label prescription during their treatment. Overall, between 80 and 90 percent of medical and psyciatric patients are prescribed medicine for off-label uses.
According to Research Director at The Independent Review, Alexander Tabarrok, there are three main reasons for prescribing medicine off-label. First, as new medicines are introduced to the marked, the standard of care’s best practices change—usually more quickly than the FDA approves new uses for existing medicines. Second, unfortunately, best practices do not work for everyone; therefore, when a patient has exhausted all labeled treatments, new approaches may be taken. Last, for the FDA to approve an older medicine for a new use, it is often an expensive and long process. Therefore, clinical trials and research lead to information about off-label use that physicians may try.
Off-Label Use Rising
For example, Taxol, a medicine used to treat ovarian cancer was used off-label for years to treat breast cancer, before being approved by the FDA. Also, the drug trimethoprim/sulfamethoxazole is used off-label to treat pneumonia, Chlamydia, meningitis, and sinusitis. Aspirin was used off-label for years to treat heart attacks, before it received FDA approval.
 Baldwin, D., & Kosky, N. (n.d.). Off-label prescribing in psychiatric practice. Advances in Psychiatric Treatment. Retrieved February 15, 2013, from apt.rcpsych.org/content/13/6/414.full
 Tabarrok, A. (2000). Assessing the FDA via the Anomaly of Off-Label Drug Prescribing. The Independent Review, 1(1), 25-53. Retrieved February 15, 2013, from http://www.independent.org/pdf/tir/tir_05_1_tabarrok.pdf off-label.