Profile of Adverse Drug Reactions with Fixed Drug Combinations: How Big is the Problem.

ABSTRACT

The current study was undertaken to analyze the profile of adverse drug reaction (ADR) contributed by fixed drug combinations (FDC). A cross-sectional, retrospective study was conducted over a period of 2 years to evaluate the profile of ADR contributed by FDC using suspected ADR data collection form used under Pharmacovigiliance Programme of India (PvPI). A total number of 2242 ADRs were reported during the study period of two years out of which drug combinations responsible for ADRs were 589 (26.27%). Fixed drug combinations (FDC) contributing to ADRs were 88(3.9%). As per latest WHO essential drug list, irrational FDC were responsible for 83 (3.70%) accounting 94.3% of the total FDC. Whereas, only 5(0.2%) of rational FDC contributed to the total pool of ADRs. Most frequent drug combination contributing to ADR was of anticancer drugs leading to vomiting and alopecia, where as most common irrational FDC was aceclofenac plus thiocolchicoside and ofloxacin plus ornidazole leading insomnia & rash respectively. Levodopa plus carbidopa and trimethoprim plus sulphamethoxazole were two common rational FDC contributing to ADRs. The above results underscores that drug combinations and FDC as well as irrational FDC substantially contribute towards the pool of total ADRs.