Abstract:
Background: Fixed dose drug combinations (FDCs) possess a higher risk of
causing adverse drug reactions (ADRs) compared to a drug used individually.
This study analyzes the pattern of ADRs caused due to the use of FDCs in a
tertiary care hospital.
Methods: A prospective, spontaneous ADR reporting study was conducted for
two years at a tertiary care hospital. ADRs reported due to suspected FDC use
were evaluated for causality (WHO-UMC probability scale), severity (adapted
Hartwig scale) and avoidability (Modified Hallas J. et al. scale).
Results: Of the 29 (96.67%) cutaneous ADRs reported, 19 (63.34%) ADRs
were due to irrational FDCs, of which 16 (53.34%) were ‘probable’, 13
(43.34%) were ‘possibly avoidable’ and 13 (43.34%) were ‘mild/level 2’ on the
severity scale.
Conclusion: Irrational FDCs carry a higher risk of causing cutaneous ADRs.
Awareness and regular reporting of such ADRs can help physicians fight the
evil of irrational prescribing.
