Licensed indications for medicines were designed to regulate the claims that can be made about a medicine by a pharmaceutical company. Off-label prescribing (i.e. prescribing a drug for an indication outside of that for which it is licensed) is legal and an integral part of medical practice. In psychiatry, off-label prescribing is common and gives clinicians scope to treat patients who are refractory to standard therapy or where there is no licensed medication for an indication. However, efficacy or safety of such off-label use may not be established.
There is a growing list of licensed indications for atypical antipsychotics (AAP) beyond schizophrenia and bipolar affective disorder, and also more evidence for other indications where pharmaceutical companies have not obtained a license. Pharmaceutical companies have promoted AAPs for off-label indications to increase sales and consequently have been fined by the US FDA for this.
Since the 1990s, AAP use has expanded considerably, for example, the off-label use of quetiapine alone accounted for an estimated 17% of the AAP spend in New Zealand in 2010. There are a number of potential problems with the expanded use of AAPs outside of schizophrenia and related psychoses. A larger population will be exposed to their adverse effects, which include weight gain, type 2 diabetes mellitus, sudden cardiac death and increased mortality rates in the elderly with dementia. There are also concerns with the abuse of these agents, in particular quetiapine.
Given that an increasing percentage of the population is being treated with these agents, off-label prescribing of AAPs is a cause for concern; they have a propensity to cause significant side effects and their efficacy and long-term safety for most off-label indications remains largely unknown, and therefore the risks and benefits of their use should be carefully weighed up prior to prescribing these agents off-label.
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The authors thank Professor Richard Porter for his assistance in reviewing this paper.
Andrew McKean has received funding for travel and accommodation assistance to attend meetings from Janssen-Cilag and Sanofi Aventis. He has also received honorarium from Novartis for performing lectures.
Erik Monasterio has previously received honoraria presentation payments and travel and accommodation assistance from Janssen Cilag, Eli Lilly and Sanofi Aventis, but not in the last 5 years.
The authors received no external funding to prepare this paper.
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McKean, A., Monasterio, E. Off-Label Use of Atypical Antipsychotics. CNS Drugs 26, 383–390 (2012). https://doi.org/10.2165/11632030-000000000-00000