Comparative Safety Assessment Study for Drospirenone Induced Gallbladder Diseases Using the Adverse Drug Reaction Database of USA, Europe, and Canada

Abstract

Background: Gallstone disease (GSD) is one of the most common gastroenterological disorders. It is known that drospirenone causes small increased risk of gallbladder diseases. However, the risk may vary between different adverse drug reaction databases.

Objective: The purpose of this studty is to examine the safety and risk association between hormonal contraceptive drospirenone and gallbladder diseases using adverse drug reaction database of USFDA's Federal Adverse Events Reporting System (FAERS), Europe's Eudravigilance (EV) and Canada's Canada Vigilance Adverse Reaction Online Database (CVARD).

Methods: Individual Case Safety Reports of patients till October 2019 were downloaded from the Federal Adverse Event Reporting System, Eudravigilance, and Canadian database. These reports contained information on adverse events associated with all other drugs inclusive of drospirenone. The disproportionality method of data mining was used to calculate the risk association.

Results: The lower limit of 95% CI of PRR was 3.27, 3.47 and 3.76, PRR was 33.08, 41.35 and 115.42, ROR was 37.20, 44.61 and 127.19, Chi-square value was 126572.89, 110392.95 and 362.46, and IC-2SD value was 0.16, 0.17, and 1.21 for FAERS, EU, and CVARD respectively indicating a week signal. Also, all the calculated parameters were above the threshold value.

Conclusion: From our study, it was clear that the risk between drospirenone and gallbladder diseases was very low among three databases. There was no harm in prescribing this drug for a contraceptive action.

Keywords: CVARD.; Drospirenone; FAERS; eudravigilance; gallbladder diseases; pharmacovigilance.