Fatal adverse drug reactions: Experience of adverse drug reactions in a tertiary care teaching hospital of North India - A case series

Annil Mahajan; Vivek Mahajan; Vishal R. Tandon; Vijay Khajuria; Zahid Gillani; Vijant Chandail

doi:10.4103/0972-5229.132499

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Fatal adverse drug reactions: Experience of adverse drug reactions in a tertiary care teaching hospital of North India - A case series

Annil Mahajan, Vivek Mahajan, Vishal R. Tandon, Vijay Khajuria, Zahid Gillani, Vijant Chandail

Keywords : Adverse drug reactions, drug safety, fatal ADR, mortality

Citation Information : Mahajan A, Mahajan V, Tandon VR, Khajuria V, Gillani Z, Chandail V. Fatal adverse drug reactions: Experience of adverse drug reactions in a tertiary care teaching hospital of North India - A case series. Indian J Crit Care Med 2014; 18 (5):315-319.

DOI: 10.4103/0972-5229.132499

License: CC BY-ND 3.0

Published Online: 01-05-2014

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Abstract

Medical burden of fatal adverse drug reactions (FADRs) is significant. The epidemiological data on FADR do exist from the western world, but there is scanty from India. We hereby report a case series of FADRs recorded in a 2 years period. Point prevalence of FADRs was 0.223%. Point prevalence of all cause death in the hospital was 1.20%. The drugs causing FADRs were injection bupivacaine, amphotericin B, directly observed treatment short-course Category-1, injection streptokinase, and tablet ferrous sulfate. All these FADR were labeled as possible expect one case as probable. All FADR were labeled as type A. In three out of five the central nervous system was involved, while the hepatic system and multiorgan failure accounted for one case each. Two cases each were acute and subacute, while one was latent in nature. Reporting of FADRs shall go a long way in patient safety.

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Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA 1998;279:1200-5.
Shepherd G, Mohorn P, Yacoub K, May DW. Adverse drug reaction deaths reported in United States vital statistics, 1999-2006. Ann Pharmacother 2012;46:169-75.
Wester K, Jönsson AK, Spigset O, Druid H, Hägg S. Incidence of fatal adverse drug reactions: A population based study. Br J Clin Pharmacol 2008;65:573-9.
Leone R, Sottosanti L, Luisa Iorio M, Santuccio C, Conforti A, Sabatini V, et al. Drug-related deaths: An analysis of the Italian spontaneous reporting database. Drug Saf 2008;31:703-13.
Nair PS, Moorthy PK, Yogiragan K. A study of mortality in dermatology. Indian J Dermatol Venereol Leprol 2005;71:23-5.
Ramesh M, Pandit J, Parthasarathi G. Adverse drug reactions in a South Indian hospital - Their severity and cost involved. Pharmacoepidemiol Drug Saf 2003;12:687-92.
Pardo Cabello AJ, González Contreras LG, Manzano Gamero MV, Gómez Jiménez FJ, Puche Cañas E. Prevalence of fatal adverse drug reactions in hospitalized patients. Int J Clin Pharmacol Ther 2009;47:596-602.
Wester K, Jönsson A, Spigset O, Hägg S. Spontaneously reported fatal suspected adverse drug reactions: A 10-year survey from Sweden. Pharmacoepidemiol Drug Saf 2007;16:173-80.
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:239-45.
Edwards IR, Aronson JK. Adverse drug reactions: Definitions, diagnosis, and management. Lancet 2000;356:1255-9.

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