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CC BY-NC-ND 4.0 · Indian J Med Paediatr Oncol 2017; 38(02): 140-145
DOI: 10.4103/ijmpo.ijmpo_18_16
Original Article

Pattern of Adverse Drug Reactions to Anticancer Drugs: A Quantitative and Qualitative Analysis

Shruti Singh
Department of Pharmacology, AIIMS, Patna, Bihar, India
,
DC Dhasmana
Department of Pharmacology, HIMS, Dehradun, India
,
Manisha Bisht
Department of Pharmacology, AIIMS, Rishikesh, Uttarakhand, India
,
Prashant Kumar Singh
Department of Surgery, AIIMS, Patna, Bihar, India
› Author Affiliations Financial support and sponsorship Nil.
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Abstract

Introduction: Anticancer drugs contribute significantly to the global burden of adverse drug reactions (ADRs). Any attempt to quantify their magnitude and provide upgraded knowledge would help oncologists in writing safer prescriptions. Aim: This observational follow-up study was conducted on newly diagnosed cancer patients receiving anticancer therapy with an aim to determine the frequency, severity, causality, predictability, and preventability of ADRs. Subjects and Methods: The patients were followed up for 6 months for the appearance of adverse events. Data were analyzed using IBM SPSS Statistics for Windows, Version 22.0. (Armonk, NY) and presented in the form of descriptive statistics. Results: Each patient was prescribed approximately 6.85 ± 1.51 (mean ± standard error) drugs on average. All the patients (100%) receiving anticancer chemotherapy had ADRs. Alopecia, nausea and vomiting, burning tingling, and numbness were the most frequently encountered ADRs. The incidence of alopecia (P < 0.0004), nausea (P < 0.03), and oral ulceration (P < 0.02) was higher in females. Maximum reactions were of Grade 2 (69.53%). Most of the reactions (75.80%) appeared within 10 days of receiving the first cycle. 99.58% reactions were not serious. According to the WHO – The Uppsala Monitoring Centre criteria, 99.47% ADRs fell in possible category. According to the Naranjo's algorithm, 100% ADRs fell in probable category. About 94.80% reactions were found to be predictable. About 56.47% reactions were probably preventable, and 43.53% reactions were not preventable. Conclusion: Multiple ADRs were seen in newly diagnosed cancer patients. Most of them were predictable, of mild-to-moderate severity, nonserious, and preventable. A majority of the ADRs recovered over time.

Keywords

Adverse drug reactions - anticancer drugs - predictability - preventability - severity


Publication History

Article published online:
06 July 2021

© 2017. Indian Society of Medical and Paediatric Oncology. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/.)

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  • References

  • 1 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.
  • 2 Surendiran A, Balamurugan N, Gunaseelan K, Akhtar S, Reddy KS, Adithan C. Adverse drug reaction profile of cisplatin-based chemotherapy regimen in a tertiary care hospital in India: An evaluative study. Indian J Pharmacol 2010;42:40-3.
  • 3 Routledge PA, O'Mahony MS, Woodhouse KW. Adverse drug reactions in elderly patients. Br J Clin Pharmacol 2004;57:121-6.
  • 4 Nayak S, Acharjya B. Adverse cutaneous drug reaction. Indian J Dermatol 2008;53:2-8.
  • 5 The Use of WHO - UMC System for Standardised Case Causality Assessment. Available from: http://www.who-umc.org/graphics/24734.pdf. [Last accessed on 2015 May 20].
  • 6 Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. Amethod for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:239-45.
  • 7 Lau PM, Stewart K, Dooley M. The ten most common adverse drug reactions (ADRs) in oncology patients: Do they matter to you? Support Care Cancer 2004;12:626-33.
  • 8 Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992;49:2229-32.
  • 9 Narang AS, Desai DS. Anticancer drug development: Unique aspects of pharmaceutical development. Pharmaceutical Perspectives of Cancer Therapeutics. New York, USA: Bristol Myers Squibb Co; 2009 p. 49-89.
  • 10 Guo HJ, Ren F, Zhang D, Ji M. Monitoring report on 341 cases of adverse reactions caused by antitumor drugs. Afr J Microbiol Res 2012;6:3774-7.
  • 11 Vijayalakshmi MK, Palatty PL, Bhat P, Dinesh M. A comparative assessment of the ADR profile in various anti-cancer regimens. J Clin Diagn Res 2011;5:1209-13.
  • 12 Rademaker M. Do women have more adverse drug reactions? Am J Clin Dermatol 2001;2:349-51.
  • 13 Domecq C, Naranjo CA, Ruiz I, Busto U. Sex related variation in the frequency and characteristics of ADRs. Intern J Clin Pharmacol Ther Toxicol 1998;46:505-11.
  • 14 Trüeb RM. Chemotherapy-induced alopecia. Semin Cutan Med Surg 2009;28:11-4.
  • 15 Pesce A, Cassuto JP, Joyner MV, DuJardin P, Audoly P. Scalp tourniquet in the prevention of chemotherapy-induced alopecia. N Engl J Med 1978;298:1204-5.
  • 16 Tran D, Sinclair RD, Schwarer AP, Chow CW. Permanent alopecia following chemotherapy and bone marrow transplantation. Australas J Dermatol 2000;41:106-8.
  • 17 Hesketh PJ. Chemotherapy-induced nausea and vomiting. N Engl J Med 2008;358:2482-94.
  • 18 Gandara DR, Roila F, Warr D, Edelman MJ, Perez EA, Gralla RJ. Consensus proposal for 5HT3 antagonists in the prevention of acute emesis related to highly emetogenic chemotherapy. Dose, schedule, and route of administration. Support Care Cancer 1998;6:237-43.
  • 19 Hesketh PJ, Grunberg SM, Gralla RJ, Warr DG, Roila F, de Wit R, et al. The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: A multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin – The Aprepitant Protocol 052 Study Group. J Clin Oncol 2003;21:4112-9.