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Year : 2018  |  Volume : 40  |  Issue : 4  |  Page : 390-391  

Off-label psychotropics use: Isn't it now an inevitable and a “norm” in psychiatry?

Central Institute of Psychiatry, Ranchi, Jharkhand, India

Date of Web Publication16-Jul-2018

Correspondence Address:
Dr. Sourav Khanra
QTR No. 8, Type IV QTR, Central Institute of Psychiatry, Ranchi - 834 006, Jharkhand
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/IJPSYM.IJPSYM_563_17

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How to cite this article:
Khanra S, Das B. Off-label psychotropics use: Isn't it now an inevitable and a “norm” in psychiatry?. Indian J Psychol Med 2018;40:390-1

How to cite this URL:
Khanra S, Das B. Off-label psychotropics use: Isn't it now an inevitable and a “norm” in psychiatry?. Indian J Psychol Med [serial online] 2018 [cited 2020 Jan 18];40:390-1. Available from:


“Off-label use” refers to the use of a drug outside the terms of its marketing authorization. It includes prescribing for an unlicensed indication like in unapproved indication, age group, dosage, or in unapproved form of administration.[1],[2] In principle, though it may not be compliant to the ethics in clinical practice, reports of off-label use of psychotropics have been widespread across clinical diagnoses and age groups.[1],[3],[4],[5],[6],[7],[8],[9],[10],[11] Among all medications, psychotropics are one of the most commonly prescribed for off-label purpose.[5],[12] A few studies from the Indian subcontinent had found that off-label use of psychotropics was seen in a significant proportion of prescriptions (up to 42%) and off-label uses were most common for indications (48.9%) followed by for dose (37.2%).[9],[10] Apart from the ethical and biological concerns arising from the unexpected adverse effects, off-label use also has an economic impact. In the United States, off-label use of central nervous system drugs contributes to 25%–80% of a drug's annual sales, and off-label indications for antidepressants, anticonvulsants, and antipsychotics are expanding each year.[5] All these drew our attention to the reasons behind the off-label prescription of psychotropics.

Factors commonly taken into consideration while choosing a psychotropic are the clinical diagnosis made, clinician's own experience with the diagnosis and the index psychotropic, evidence for efficacy of the particular psychotropic for that diagnosis, physical and family factors of index patient, and the side effect profile of the psychotropic. A clinical diagnosis naturally warrants that one prescribes a medication approved for it. In a review, Devulapalli et al.[5] concluded that majority of psychiatric diagnoses (up to 88%) from the Diagnostic and Statistical Manual IV – Text Revision (DSM IV – TR) had no approved medication from the Food and Drug Administration (FDA). Now that researches have confirmed the efficacy of several categories of psychotropics (e.g., atypical antipsychotics, antidepressants, anxiolytics, mood stabilizers, benzodiazepines, and stimulants) for other indications apart from the ones approved by the FDA. When clinicians come across a diagnosis which has no approved medication, the next reasonable step expectedly would be to search for medications with evidence-based efficacy, albeit a weak one. It would surely not be ethical to refrain from prescribing and let patients continue suffering for the reason that there is no approved or recommended psychotropic available in any drug regulation authority or in any guidelines. Even if the clinical diagnosis being made has an approved medication, it may so happen that the patient may not show adequate response or the illness has become refractory. Eventually, the clinician will have to prescribe a medication off-label.

Furthermore, psychopharmacotherapy does not just involve choice of molecules. For most psychotropics, several issues such as minimum and maximum dosage across age groups, titration regimens, discontinuation schedules, and status in combination or adjunct therapies are rarely adequately researched and remain beyond the purview of being “on label.” Often, depending on the illness profile, the clinician has to prescribe a higher dosage than recommended. Conversely, sometimes, less than the minimum dosage can evoke an adequate response and a full recovery. Likewise, often, dosage schedules other than the recommended ones are found to be efficacious or they have to be changed to optimize the response and patient satisfaction. In addition, titration schedules recommended by the FDA do not suit all patients and are required to be tailored among patients, and this too would fall under off-label use.

Beyond the above factors related to medications, there are a few other factors that make the off-label use of psychotropics almost inevitable in Psychiatry. Unlike other branches of medicine, etiology of most psychiatric disorders remains unknown or, to say the least, remains nonspecific, thereby making it difficult to specify the target for successive upcoming research molecules. For instance, in case of antipsychotics and antidepressants, most of the molecules have affinity to more than one receptor and have similar receptor profiles, only with varying amount of affinity.

Thus, when the need arises, in a range of clinical situations, the clinicians should be in-principle reasonable enough to prescribe medications even if that falls under off-label use.

Furthermore, the process of approval for a specific molecule for a specific clinical condition is always a lengthy and time-consuming one. Several phases of trials are necessary before a proposal can be submitted to the FDA or other drug regulatory agencies. As conducting large-scale trials involves huge funding, such trials are sponsored by pharmaceutical companies, rising the concern of potential bias. It cannot be expected that trials would be conducted for every clinical condition for which there are no approved medications. In most cases, it is the sponsor's decision as to which drug is to be tested and which clinical condition is to be addressed. Thus, off-label use of psychotropics has become an important approach in clinical psychopharmacology and we believe that it will remain so in spite of several concerns.

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Conflicts of interest

There are no conflicts of interest.

   References Top

Haw C, Stubbs J. A survey of off-label prescribing for inpatients with mild intellectual disability and mental illness. J Intellect Disabil Res 2005;49:858-64.  Back to cited text no. 1
Stafford RS. Regulating off-label drug use – Rethinking the role of the FDA. N Engl J Med 2008;358:1427-9.  Back to cited text no. 2
Barbui C, Ciuna A, Nosé M, Patten SB, Stegagno M, Burti L, et al. Off-label and non-classical prescriptions of antipsychotic agents in ordinary in-patient practice. Acta Psychiatr Scand 2004;109:275-8.  Back to cited text no. 3
Haw C, Stubbs J. Off-label use of antipsychotics: Are we mad? Expert Opin Drug Saf 2007;6:533-45.  Back to cited text no. 4
Devulapalli KK, Nasrallah HA. An analysis of the high psychotropic off-label use in psychiatric disorders the majority of psychiatric diagnoses have no approved drug. Asian J Psychiatr 2009;2:29-36.  Back to cited text no. 5
Lee E, Teschemaker AR, Johann-Liang R, Bazemore G, Yoon M, Shim KS, et al. Off-label prescribing patterns of antidepressants in children and adolescents. Pharmacoepidemiol Drug Saf 2012;21:137-44.  Back to cited text no. 6
Czaja AS, Valuck R. Off-label antidepressant use in children and adolescents compared with young adults: Extent and level of evidence. Pharmacoepidemiol Drug Saf 2012;21:997-1004.  Back to cited text no. 7
Kharadi D, Patel K, Rana D, Patel V. Off-label drug use in psychiatry outpatient department: A prospective study at a tertiary care teaching hospital. J Basic Clin Pharm 2015;6:45-9.  Back to cited text no. 8
Jacob MK, Ammu A, Eapen BA, Behnan A, Prabha S, Devassy KA, et a l. Evaluation of off label drug use in the outpatient department of a psychiatry hospital. Int J Pharm Sci Rev Res 2016;40:206-10.  Back to cited text no. 9
Sridharan K, Arora K, Chaudhary S. Off-label drug use in psychiatry: A retrospective audit in a tertiary care hospital. Asian J Psychiatr 2016;24:124.  Back to cited text no. 10
Sharma AN, Arango C, Coghill D, Gringras P, Nutt DJ, Pratt P, et al. BAP position statement: Off-label prescribing of psychotropic medication to children and adolescents. J Psychopharmacol 2016;30:416-21.  Back to cited text no. 11
Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med 2006;166:1021-6.  Back to cited text no. 12


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