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.

• Authors: Hasitha Diana Manohar, Shalini Adiga, Joseph Thomas, Ajitha Sharma
• Journal: Indian journal of pharmacology (Indian J Pharmacol) 2016 Sep-Oct Vol. 48 Issue 5 Pg. 509-514 ISSN: 1998-3751 [Electronic] India
• PMID: 27721535 (Publication Type: Journal Article, Observational Study)

Chemical References

• Antineoplastic Agents
• Taxoids
• Vinca Alkaloids

Topics

• Adult
• Antineoplastic Agents (adverse effects)
• Drug-Related Side Effects and Adverse Reactions (epidemiology)
• Female
• Humans
• Incidence
• India (epidemiology)
• Male
• Microtubules (drug effects)
• Middle Aged
• Pharmacovigilance
• Taxoids (adverse effects)
• Vinca Alkaloids (adverse effects)