Various concerns have been raised in media as well as published reports for the association of Drospirenone and Gallbladder diseases.

OBJECTIVES The objective of the study was to identify possible signal induced by drospirenone and its significance with gall bladder diseases by searching database from Eudravigilance. A total of 42902 reports of patients till September 2018 were downloaded from Eudravigilance website. These reports contained information of adverse events associated with all other drugs inclusive of Drospirenone.

METHODS Signal detection were determined by proportional reporting ratio (PRR), reporting odds ratio (ROR), PRR calculated by chi-square statistics, 95% confidence interval of PRR, observed to expected (O/E) ratio and De Mouchel method calculated PRR. Information component (IC) was given by Bayesian confidence propagation neural network. A total of 3823 reports of Drospirenone induced gallbladder diseases were reported in Eudravigilance database.

RESULTS The PRR was found to be 125.31 and by the Du Mouchel method it was 1.112. The PRR calculated by chi-square statistics was 904.22 (p-value < 0.0001). The lower and upper limits of 95% CI of PRR was found to be 4.43 and 4.87, respectively. The O/E ratio was found to be 1.112 and ROR was found to be 40, also IC – 2 SD is 0.12 indicating a significant weak signal associated with drospirenone and gall bladder diseases.

CONCLUSIONS Study shows a very low risk associated with drospirenone and gallbladder diseases. These data will enhance information available to healthcare professional and may found useful in management of women’s health.