Comparative Adverse Drug Profile of Deflazacort Vs Conventional Corticosteroids in Spontaneous Reporting System of Pharmacovigilance

Corticosteroids (CS) are the most frequently used class of highly potent anti-inflammatory and immunosuppressant agents in clinical practice for various clinical indications (1). However, their long-term use is associated with serious side effects, which restrict their clinical utility (2-3). Even low dose CS treatment has been suggested to be not free from risks (4). Moreover, cutaneous adverse effects have also been reported to occur even with prolonged treatment of topical CS (5). Recently use of DFZ has increased in clinical practice. DFZ is a synthetic oxazoline derivative of prednisolone with anti-inflammatory and immunosuppressive activity (6, 7). There are studies existing in literature comparing the relative efficacy and safety of conventional CS to DFZ (8-11). These studies have shown DFZ to be as effective as prednisone or methylprednisolone (8-11). The overall incidence of adverse events in DFZ recipients has been recorded lower than that recorded in patients treated with prednisone or methylprednisolone (6). DFZ has been claimed to be associated with less serious metabolic sequelae and development of CS-induced osteoporosis (6, 7). However, we failed to cite any observational study based on spontaneous reporting of ADR comparing profile of CCS and DFZ. Hence, the current study was undertaken to evaluate and compare ADR profile of DFZ Vs CCS in spontaneous reporting system of ADRs in current Pharmacovigilance Programme of India. Material and Methods An observational prospective cross-sectional analysis was done w.e.f Nov 2010 to Nov 2013 in Adverse Drug Monitoring Centre, working under (PvPI) in a tertiary care teaching hospital from India using suspected drug reactions monitoring data collection form after due Introduction Abstract The current observational cross-sectional study was undertaken using suspected adverse drug data collection form available under (PvPI) to evaluate comparative ADR profile of DFZ Vs CCS for 3 years in spontaneous reporting system of ADRs in current PvPI. Total number of ADR reports during the study period was 3024, out of which ADRs reports due to CS were 112 accounting for a rate of 3.70%. The rate of total ADR events with CS was 4.11%. Geriatric, urban and female population predominated in contributing ADRs with both CCS and DFZ in the study. Self medication of CCS and DFZ contributed 10.95% and 7.69% of total ADRs. Oral route contributed maximal ADRs. Irrational drug prescription contributed substantially. Maximum ADRs due to CCS and DFZ were moderate, latent, non-serious, type A and were probable followed by possible in nature as per WHO UMC scale. Gastritis, new onset hypertension/ loss of hypertensive control, loss of diabetic control, obesity/overweight, dyslipedemia were common ADRs. Thus, ADRs due to CS is a substantial health problem. ADR profile did not vary although DFZ recorded less ADRs.