title: Adverse drug reactions of imatinib in patients with chronic myeloid leukemia: A single-center surveillance study.
abstract: OBJECTIVE
  To monitor the adverse drug reactions (ADRs) associated with imatinib treatment in patients with chronic myeloid leukemia (CML) in a tertiary care hospital.
  
  
  METHODS
  The study was carried out by the Departments of Pharmacology and Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India. The study was carried out from March 2012 to February 2014. The ADRs were reported in a suspected Adverse Drug Reaction Reporting form, provided by the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, Government of India. The ADRs were analyzed for their pattern, causality and severity.
  
  
  RESULTS
  A total of 326 ADRs from 81 patients were reported during the study period. The hematological toxicities were much more prominent than the non-hematological toxicities in this study. The prevalence of thrombocytopenia (21.17%) was higher compared with other reactions. Further analysis showed that most of the ADRs were mild to moderate in nature. The causality assessment revealed that the majority of the ADRs belonged to the possible category.
  
  
  CONCLUSIONS
  The present study in a tertiary care hospital suggests that hematological toxicities are predominant in CML patients treated with imatinib mesylate. The blood and lymphatic system (38.96%) was the most affected, with imatinib therapy and thrombocytopenia (21.17%) being the most commonly encountered ADRs in the present study. Thorough monitoring of ADRs is warranted for better treatment outcomes.
authors.affiliation: Department of Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
authors.forename: Jose
authors.initials: J
authors.lastname: Francis
authors.affiliation: Department of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
authors.forename: Muthiah
authors.initials: M
authors.lastname: Palaniappan
authors.affiliation: Department of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
authors.forename: Biswajit
authors.initials: B
authors.lastname: Dubashi
authors.affiliation: Department of Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
authors.forename: Suresh Chandra
authors.initials: SC
authors.lastname: Pradhan
authors.affiliation: Department of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
authors.forename: Adithan
authors.initials: A
authors.lastname: Chandrasekaran
keywords: Adverse drug reactions; chronic myeloid leukemia; hematological toxicities; imatinib mesylate; thrombocytopenia