Cutaneous adverse drug reactions with fixed-dose combinations: Special reference to self-medication and preventability

OBJECTIVES: To identify the association of cutaneous adverse drug reactions (CADRs) with use of fixed-dose combinations (FDCs) and to compare the occurrence of preventable CADRs between self-medication and prescribed medication of FDCs. PATIENTS AND METHODS: All cases of suspected CADRs with the use of FDCs were collected, and causality assessment was carried out using the WHO UMC scale. The burden of CADRs on self-medication and prescribed medication was found out. Preventability status was analyzed by Schumock and Thornton Criteria and compared between self-medication and prescribed medication. RESULTS: A total of 74 CADRs were detected; 68.91% were detected with antimicrobial and 31.09% with nonsteroidal anti-inflammatory drug-based FDCs. Fluoroquinolones + nitroimidazole was the most commonly suspected medications. Majority of CADRs (44.59%) were fixed-drug eruptions, which was significantly higher than others (P = 0.002). Analysis of preventability showed that there was a significantly higher occurrence of definitely preventable CADRs in self-medication group (40%) in comparison to prescribed group (6.81%), P = 0.028. CONCLUSIONS: Self-medication with FDCs is quite common and associated with a higher rate of preventable CADRs in comparison to that in prescribed medication.