| RESEARCH ARTICLE |
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| Year : 2016 | Volume
: 48
| Issue : 5 | Page : 509-514 |
Adverse drug reaction profile of microtubule-damaging antineoplastic drugs: A focused pharmacovigilance study in India
Hasitha Diana Manohar1, Shalini Adiga2, Joseph Thomas3, Ajitha Sharma4
1 Department of Pharmacology, Karpaga Vinayaga Institute of Medical Sciences and Research, Dr. M. G. R. Medical University, Chennai, Tamil Nadu, India
2 Department of Pharmacology, Kasturba Medical College, Manipal University, Manipal, Karnataka, India
3 Department of Medical Oncology, Kasturba Medical College, Manipal University, Manipal, Karnataka, India
4 Department of Pharmacology, Pondicherry Institute of Medical Sciences, Puducherry, India
Correspondence Address:
Dr. Hasitha Diana Manohar
Department of Pharmacology, Karpaga Vinayaga Institute of Medical Sciences and Research, Dr. M. G. R. Medical University, Chennai, Tamil Nadu
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/0253-7613.190725
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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