Adverse Drug Reactions in Rheumatoid Arthritis Patients Taking Combination DMARDs

Abstract

Aim - To ascertain the adverse drug reactions among RA patients taking combination DMARDs Methods- It’s a prospective single centre controlled study. Patients of Reumatoid arthritis were divided into 2 study groups, Group-1 patients were given Methotrexate (MTX) oral weekly with Hydroxychloroquine oral daily. Group-2 patients were given Methotrexate (MTX) oral weekly with Salfasalazine oral daily in divided doses. Apart from the study medications, all patients were also given concomitant medications. The data was obtained from suspected ADRs reporting forms, between January 2014 to January 2015 from the Rheumatology OPD, Medicine department to the ADRs monitoring centre attached to department of Pharmacology under the Pharmacovigilance programme of India (PvPi). The reported ADRs were assessed for causality using WHO causality assessment scale. The severity was assessed using Hartwig and Siegel scale. Observations: 131 patients who entered the study, 68 were study assigned to receive Methotrexate and Hydroxychloroquine (Group I) and 63 to receive Methotrexate and Sulfasalazine. In the study, in total 99 ADRs were reported from 53 ADR Forms. Most common occurring ADRs were nausea and vomiting in both the treatment groups. Different adverse drug reactions like nausea, blurring of vision, hyperpigmentation of skin, anaemia, epigastric pain, breathlessness were observed amongst patients in group-1.Whereas in group-2 patients the nausea, diarrhoea, headache, hepatotoxicity and leucopenia were seen. Conclusions: DMARD’s combination cause more but tolerable adverse effects. Combination DMARD regimens are safe for use in Rheumatoid arthritis to control disease activity with tolerable, transient and reversible adverse effects.