Document Type : Original Article
Authors
1 Department of Pharmacy Practice, JSS University, Mysore, India
2 Department of Psychiatry, JSS Hospital, Mysore, India
Abstract
Objective: Antipsychotics have revolutionized psychiatry by allowing significant numbers
of patients in long‑term hospital settings to be discharged and successfully maintained in the
community. However, these medications are also associated with a range of adverse events
ranging from mostly annoying to rarely dangerous. This study is carried out to identify the
adverse drug reactions (ADRs) to antipsychotics and its management in psychiatric patients.
Methods: Prospective interventional study was conducted in the psychiatric unit of a tertiary
care hospital. Patients of any age and either sex prescribed with at least one antipsychotic
were included and monitored for ADRs.
Findings: Among the 517 patients receiving antipsychotics, a total of 289 ADRs were
identified from 217 patients at an overall incidence rate of 41.97%. Sixty‑seven different
kinds of ADRs were observed in the study patients. Central and peripheral nervous system
was the most commonly affected system organ class (n = 59) and weight gain (n = 30) was
the most commonly observed ADR. Olanzapine was most commonly implicated in reported
ADRs(n = 92) followed by risperidone (n = 59). Of the 289 ADRs, 80% required interventions
including cessation of drug and/or specific/symptomatic/nonpharmacological treatment.
Conclusion: This post marketing surveillance study provides a representative data of the
ADR profile of the antipsychotics likely to be encountered in psychiatric patients in an
Indian tertiary care hospital.
Keywords
managing antipsychotic drug treatment side effects in the
elderly. Prim Care Companion J Clin Psychiatry 2004;6:14‑9.
2. Carlson HE, Correll CU. Adverse effects of antipsychotics and
mood stabilizers. Psychiatric times, 2010. Available from: http://
www.psychiatrictimes.com. [Last accessed on 2014 Jan 12].
3. Popli AP, Hegarty JD, Siegel AJ, Kando JC, Tohen M. Transfer
of psychiatric inpatients to a general hospital due to adverse
drug reactions. Psychosomatics 1997;38:35‑7.
4. Rothschild JM, Mann K, Keohane CA, Williams DH, Foskett C,
Rosen SL, et al. Medication safety in a psychiatric hospital. Gen
Hosp Psychiatry 2007;29:156‑62.
5. Sengupta G, Bhowmick S, Hazra A, Datta A, Rahaman M.
Adverse drug reaction monitoring in psychiatry out‑patient
department of an Indian teaching hospital. Indian J Pharmacol
2011;43:36‑9.
6. Grohmann R, Hippius H, Helmchen H, Rüther E, Schmidt LG.
The AMUP study for drug surveillance in psychiatry - A summary
of inpatient data. Pharmacopsychiatry 2004;37 Suppl 1:S16‑26.
7. Carlini EL, Nappo SA. The pharmacovigilance of psychoactive
medications in Brazil. Rev Bras Psiquiatr 2003;25:200‑5.
8. Zabo CP. Common adverse drug reactions with psychiatric
medications and an approach to their management. Contin
Med Educ 2011;29:230‑2.
9. Kaushik S, Lindenmayer JP, Khan A. Management of
antipsychotic side effects. Prim Psychiatry 2007;14:77‑82.
10. Sharif ZA. Overview of safety and tolerability of atypical
antipsychotics used in primary care. JClin Psychiatry 2003;5:14‑21.
11. Hamer S, Haddad PM. Adverse effects of antipsychotics as
outcome measures. Br J Psychiatry Suppl 2007;50:s64‑70.
12. Pahari N, Tripathi SK, Maity T, Gupta BK, Bagchi C,
Mondal DK. Evaluation and analysis of adverse drug reactions
of second generation antipsychotics in a psychiatry out‑patient
department. Int Pharm Pharm Sci 2012;4:158‑62.
13. Piparva KG, Buch JG, Chandrani KV. Analysis of adverse drug
reactions of atypical antipsychotic drugs in psychiatry OPD.
Indian J Psychol Med 2011;33:153‑7.
14. Lahon K, Shetty H, Paramel A, Sharma G. Adverse drug
reaction monitoring of antipsychotics, antidepressants and
mood stabilizers in the psychiatric outpatient unit of a
teaching hospital‑a retrospective study. Int J Pharma Bio Sci
2012;3:470‑8.
15. Shah LP, Ayyar KS, Agarawal BR, Pradhan PV,
Bagadia VN, Gupta KC, et al. Drug surveillance programme
in psychiatry - Adverse durg reactions. Indian J Psychiatry
1983;25:229‑34.
16. Thomas M, Boggs AA, DiPaula B, Siddiqi S. Adverse
drug reactions in hospitalized psychiatric patients. Ann
Pharmacother 2010;44:819‑25.
17. Yonkers KA, Kando JC, Cole JO, Blumenthal S. Gender
differences in pharmacokinetics and pharmacodynamics of
psychotropic medication. Am J Psychiatry 1992;149:587‑95.
18. Kwak WJ, Patel A, Haq F, Siddiqui F, Younis M, Raza S, et al.
Antipsychotic‑induced euprolactinemic galactorrhea in an
adolescent girl: A case report. Prim Care Companion CNS
Disord 2012;14:1‑6.
19. Windgassen K, Wesselmann U, Schulze Mönking H.
Galactorrhea and hyperprolactinemia in schizophrenic patients
on neuroleptics: Frequency and etiology. Neuropsychobiology
1996;33:142‑6.
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