Adverse drug reaction profile of microtubule-damaging antineoplastic drugs: A focused pharmacovigilance study in India

Content Provider	Scilit
Author	Manohar, Hasitha Adiga, Shalini Thomas, Joseph Sharma, Ajitha
Copyright Year	2016
Abstract	The aim of the study was to analyze the adverse drug reaction (ADR) profile of microtubule-damaging antineoplastic drugs (taxanes and vinca alkaloids) and to look for unexpected ADRs among the local population. Focused study on these drugs, rampantly used in oncology department for a wide variety of tumors including early and advanced malignancies, would enable better treatment care by physicians. Data on ADRs were collected from the cancer patients belonging to both gender and of all ages, on taxanes- or vinca-based cancer chemotherapy and reported in the Indian Pharmacopoeia Commission form. Causality was assessed using the WHO criteria and Naranjo's Algorithm. Preventability and severity of ADRs were also assessed. A total of 97 ADRs were reported among 488 patients on microtubule-damaging anticancer drugs admitted over a period of 1 year. The incidence rate was 19.87%. Gastrointestinal system (40.2%) was the most affected followed by bone marrow (33%) and skin (8.2%). The highest incidence of ADRs was reported among paclitaxel (54.6%), and vincristine (39.2%). Most of the reported ADRs were of milder nature and preventable. The WHO causality assessment scale indicated 71.1% possible reactions. This study showed that most ADRs are preventable with effective ADR monitoring. There is a great need to create awareness among healthcare professionals regarding the importance of the pharmacovigilance system. Judicious use of the preventive measures will lead to a reduction in the incidence of ADRs due to the drug armamentarium, thereby enabling additional economic benefit to the patient and society.
Related Links	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5051243/pdf http://www.ijp-online.com/article.asp?issn=0253-7613;year=2016;volume=48;issue=5;spage=509;epage=514;aulast=Manohar;type=2
Ending Page	514
Page Count	6
Starting Page	509
File Format	XHTML
ISSN	02537613
e-ISSN	19983751
DOI	10.4103/0253-7613.190725
Journal	Indian Journal of Pharmacology
Issue Number	5
Volume Number	48
Language	English
Publisher	Medknow
Access Restriction	Open
Subject Keyword	Toxicology Adverse Drug Reactions Focused Pharmacovigilance Taxanes Vinca Alkaloids Indian Journal of Pharmacology, Volume 48, Issue 5
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)