Assessment of causality and severity of various reported adverse drug reactions by different classes of anti-cancer drugs

Shaheena Rasool, Masarat Nazeer, Mehwish Majeed


Background: Chemotherapy involves highly complex regimens and hence accounts to high susceptibility towards Adverse Drug Reactions. All antineoplastic drugs have potential to cause one or more Adverse Drug Reactions which may vary from mild to severe form. So the aim of this study was to determine the prevalence of Adverse Drug Reactions in patients treated with chemotherapy.

Methods: After getting approval from the Institutional Ethical Committee, the prospective observational study was conducted in the Department of Pharmacology in association with Department of Radiation Oncology and Department of Medicine, Government Medical College, Srinagar between April 2015 to October 2016. All patients of either sex and any age receiving anti-cancer drugs in the inpatient department of radiation oncology were included. The mean age of the study population was 51 years and 53.9% of them were males and 46.1% of them were females. The WHO-UMC system was used for assessment of case programme and case reports. The severity of adverse drug reactions was determined by using modified Hart wig and Siegel scale.

Results: Most of the reported ADR’s were moderate to mild in severity according to modified Hart wig and Siegel scale. Most of the frequent ADR’s were certain followed by probable and possible according to WHO-UMC causality assessment.

Conclusions: Antineoplastic drugs have a narrow therapeutic index and the dosage needed to achieve a therapeutic response usually proves toxic to the body’s rapidly proliferating cells. Measures need to be put into place to reduce the physical, emotional and economic burden on the patient due to adverse drug reactions. Therefore, there is a need for vigilant ADR monitoring to decrease morbidity and mortality due to ADR’s which require further studies on large populations.


Anti-cancer drugs, Chemotherapy, Hart wig and Siegel scale, WHO-UMC system

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