title: Adverse drug reaction profile of microtubule-damaging antineoplastic drugs: A focused pharmacovigilance study in India.
abstract: OBJECTIVE
  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.
  
  
  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.affiliation: Department of Pharmacology, Karpaga Vinayaga Institute of Medical Sciences and Research, Dr. M. G. R. Medical University, Chennai, Tamil Nadu, India.
authors.forename: Hasitha Diana
authors.initials: HD
authors.lastname: Manohar
authors.affiliation: Department of Pharmacology, Kasturba Medical College, Manipal University, Manipal, Karnataka, India.
authors.forename: Shalini
authors.initials: S
authors.lastname: Adiga
authors.affiliation: Department of Medical Oncology, Kasturba Medical College, Manipal University, Manipal, Karnataka, India.
authors.forename: Joseph
authors.initials: J
authors.lastname: Thomas
authors.affiliation: Department of Pharmacology, Pondicherry Institute of Medical Sciences, Puducherry, India.
authors.forename: Ajitha
authors.initials: A
authors.lastname: Sharma
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D015994:Incidence; D007194:India / Q000453:epidemiology; D008297:Male; D008870:Microtubules / Q000187:drug effects*; D008875:Middle Aged; D060735:Pharmacovigilance; D043823:Taxoids / Q000009:adverse effects*; D014748:Vinca Alkaloids / Q000009:adverse effects*
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D014748:Vinca Alkaloids
keywords: Adverse drug reactions; focused pharmacovigilance; taxanes; vinca alkaloids