Adverse Drug Reactions Associated with Anthracyclinebased Chemotherapy in Mexican Cancer Pediatric Patients: Cohort Study

. Adverse drug reactions (ADR) are an important cause of illnesses and death in cancer pediatric patients. Anthracyclines are drugs used as the first-line treatment for this disease. It is necessary to apply different pharmacovigilance strategies to know the incidence, causality, and evaluation of an ADR prevention processes. The objective of this cohort study was evaluating the incidence, severity, and causality of ADRs associated with anthracycline-based chemotherapy in Mexican pediatric patients. Material and Methods. A retrospective cohort study was conducted in two pediatric institutions in Mexico. All ADRs were identified and analyzed according to pharmacovigilance guidelines. Ninety-nine patients were included in this study, 92 % had at least one ADR associated with chemotherapy. Results. A total of 718 AR were found, 354 (49.3 %) were associated, by causality analysis, as probable and definite with anthracycline-based chemotherapy. The reaction with the highest incidence was febrile neutropenia (67.7 %). The mean ADR associated with anthracycline-based chemotherapy per patient was 4 ADR / patient. Most ADRs were severe, involving hospitalization, treatment and temporary suspension of chemotherapy. Conclusions.The incidence of ADRs associated with anthracycline-based chemotherapy is high and most require monitoring and follow-up, so increasing awareness of the safety of these medications provides relevance to implement pharmacovigilance actions in pediatric hospitals.