Adverse drug reaction profile of microtubule-damaging antineoplastic drugs

A focused pharmacovigilance study in India

Hasitha Manohar, Shalini Adiga, Joseph Thomas, Ajitha Sharma

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Objectives: 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. Materials and Methods: 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. Results: 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. Conclusions: 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.

Original languageEnglish
Pages (from-to)509-514
Number of pages6
JournalIndian Journal of Pharmacology
Volume48
Issue number5
DOIs
Publication statusPublished - 01-09-2016

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Pharmacovigilance
Drug-Related Side Effects and Adverse Reactions
Microtubules
Antineoplastic Agents
India
Taxoids
Causality
Neoplasms
Incidence
Vinca
Pharmaceutical Preparations
Vinca Alkaloids
Pharmacopoeias
Drug Monitoring
Vincristine
Paclitaxel
Bone Marrow
Economics
Delivery of Health Care
Physicians

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

Cite this

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title = "Adverse drug reaction profile of microtubule-damaging antineoplastic drugs: A focused pharmacovigilance study in India",
abstract = "Objectives: 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. Materials and Methods: 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. Results: 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. Conclusions: 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.",
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Adverse drug reaction profile of microtubule-damaging antineoplastic drugs : A focused pharmacovigilance study in India. / Manohar, Hasitha; Adiga, Shalini; Thomas, Joseph; Sharma, Ajitha.

In: Indian Journal of Pharmacology, Vol. 48, No. 5, 01.09.2016, p. 509-514.

Research output: Contribution to journalArticle

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