Abstract
Various concerns have been raised in media as well as published reports for the association of Drospirenone and Gallbladder diseases. 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. 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. 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. 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.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
