Frequency of Off-label Use
Off-label use of medications is very common. Generic drugs generally have no sponsor as their indications and use expands, and incentives are limited to initiate new clinical trials to generate additional data for approval agencies to expand indications of proprietary drugs. Up to one-fifth of all drugs are prescribed off-label and amongst psychiatric drugs, off-label use rises to 31%. Among use of antipsychotic medications in the United States, a shift occurred from typical agents in 1995 (84% of all antipsychotic visits) to atypical agents by 2008 (93%). Atypical use has grown far beyond substitution for the now infrequently used typical agents. New drugs are often not tested for safety and efficacy specifically in children and even when they are tested, the results of these trials may not be disseminated to practicing physicians. A 2009 study found that 62% of U.S. pediatric office visits included off-label prescribing, with younger children at higher risk of receiving off-label prescriptions. Specialist physicians also prescribed off-label more frequently than general pediatricians.
A study published in 2006 found that off-label use was the most common in cardiac medications and anticonvulsants. This study also found that 73% of off-label use had little or no scientific support
By default use of non-approved drugs is common in obstetrics as, by 2010, during almost five decades of activity the FDA had approved only two drugs for obstetrical indications, namely oxytocin and cervidil. A small market and the high risk of medicolegal action, as exemplified by the Bendectin case, may explain the reluctance to develop drugs for approval.
Some drugs are used more frequently off-label than for their original, FDA-approved indications. A 1991 study by the U.S. General Accounting Office found that one-third of all drug administrations to cancer patients were off-label, and more than half of cancer patients received at least one drug for an off-label indication. A 1997 survey of 200 cancer doctors by the American Enterprise Institute and the American Cancer Society found that 60% of them prescribed drugs off-label. In some cases, patients may perceive the efficacy of treatments for off-label purposes to be higher than for their indicated purpose. Frequently, the standard of care for a particular type or stage of cancer involves the off-label use of one or more drugs. An example is the use of tricyclic antidepressants to treat neuropathic pain. This old class of antidepressants is now rarely used for clinical depression due to side effects, but the tricyclics are often effective for treating pain.
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