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

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.