A study on prospective monitoring of adverse drug reactions associated with hematinics at a tertiary care teaching hospital

Authors: Vinay P., Ramana P. V., Kiran B. J., Meghana K.*, Vineetha N.


Adverse reactions are the documented hazards of drug treatment and they can happen with any class of drugs and several studies exposed that the incidence is increasing with blood and blood products. The main aim of this study is to identify and analyze Adverse Drug Reactions with Hematinics in a tertiary care hospital. This prospective observational study was conducted for a period of 6 months. A total of 29 ADRs were reported during the study period with a female high proportion (79.31%), more amounts of ADRs were from Obstetrics & Gynecology and General Medicine in which the mainly affected organ systems were the skin (86.20%) and the GIT (13.79%). The hematinics mostly accounted were Iron sucrose (44.82%) followed by ferric carboxy maltose (37.93%) and Iron dextran (17.24%) in which type B reactions were more compared to type A and 72.41% of them were unpredictable. The severity assessment revealed that the majority of them were moderate reactions (62.06%). Out of the reported reactions, 58.62% were definitely preventable and a causality assessment was done which showed that 68.96% of the reactions were probable, possible (20.68%) and conditional (10.34%). Most of the patients (65.51%) were treated with Antihistamines & corticosteroids, with only anti-histamines (24.13%) and no treatment (10.34%). The study concludes that Adverse Drug Reactions with Hematinics are increasing in recent days. Better vigilance is necessary for the implementation of safe and effective treatment with hematinics for each and individual patient.

Keywords: Pharmacovigilance, Adverse Drug Reactions, Hematinics, Prospective study, Spontaneous reporting.

Article ID: 20212106