Title:Desogestrel and Severe Psychiatric Disorders: A Retrospective Analysis of Federal Adverse Event Reporting System and EudraVigilance
Volume: 16
Issue: 3
Author(s): Manan Shah and Charmy Kothari*
Affiliation:
- Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad,India
Keywords:
Desogestrel, severe psychiatric disorders, pharmacovigilance, adverse drug reaction, FAERS, eudravigilance.
Abstract:
Background: Several studies have been published which stated that there is some connection
between severe psychiatric disorders and contraceptive drug “desogestrel”. However, nothing
in the summary of product characteristics (SmPC) or patient information leaflets of desogestrel
about anxiety, more severe anxiety leading to panic attacks, or about risks of severe depression
leading to suicidal thoughts or suicide attempts.
Objective: To examine the safety and risk association between hormonal contraceptive desogestrel
among women with psychiatric disorders using adverse drug reaction database of FDA Adverse
Events Reporting System (FAERS) and EudraVigilance (EV).
Methods: Individual case safety reports (ICSRs) of only female patients from Jan 1999 to Nov
2019 and Jan 2004 to Nov 2019 were downloaded from FAERS and EV database, respectively. Reports
of drug desogestrel, dienogest, norgestimate, cyproterone acetate and drospirenone were
downloaded. Disproportionality method of data mining was used to calculate the risk association.
Results and Discussion: The lower limit of 95% CI of PRR is -0.28 and 2.02, PRR is 1.08 and
9.18, ROR is 1.09 (95%CI: 0.74, 1.59) and 9.26 (95% CI: 7.21, 11.89), Chi square value is 1.21
and 433.68, and IC-2SD is -0.27 and 2.60, respectively for data obtained from FAERS and EV.
Conclusion: From this study, we conclude that there is no new emerging signal for the drug-event
pair studied. Further study and continuous monitoring are required in future to know more about
this drug-event pair association, as severe psychiatric disorders are not yet mentioned or included
in SmPC and patient leaflet of desogestrel.
