Objective: Although generic drugs (generics) are considered equivalent in quality, efficacy, and safety to original drugs, there are some cases where switching to a generic resulted in diminished effects or adverse events. In this study, we surveyed patients with rheumatoid arthritis (RA) who had been prescribed an antirheumatic and later switched to a generic.
Methods: Subjects were 200 outpatients with RA (47 men and 153 women; mean age 59.5 years) who had been prescribed an antirheumatic; their data was confirmed from their prescription records.
Results: The drugs that were administered at our hospital are MTX (Rheumatrex®, Metolate®), SASP (Azulfidine®), BUC (Rimatil®), and TAC (Prograf®). The rate of change to the respective generic (number of changes to/number of prescriptions for a generic) was 16.4% (19/116) for MTX, 22.2% (18/81) for SASP, 11.1% (3/27) for BUC, and 7.1% (1/14) for TAC. Of the patients who were switched to a generic, 4 experienced diminished effect and 5 experienced adverse events. A diminished effect was observed in two cases with MTX and in one case each with SASP and BUC. Three cases of itching (adverse event) were observed after the switch. There was also one case each of cholecystitis and alopecia areata.
Conclusion: While in most cases no issues were observed after the switch to a generic, there were some cases where the effect was diminished or an adverse event was observed. It needs to be clearly explained to patients that there may be a diminished effect or that an adverse event could occur when switching to a generic.
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