BACKGROUND

Many studies have raised the possibility that it may cause severe Psychiatric disorders while using Desogestrel. But nothing in the summary of product characteristics (SmPCs) 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

OBJECTIVES

: 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

METHODS

: Individual Case Safety Reports of patients till November 2019 were downloaded from Federal Adverse Event Reporting System and Eudravigilance database. These reports contain information of adverse events associated with all other drugs inclusive of Desogestrel. Disproportionality method of data mining was used to calculate the risk association

RESULTS

: The lower limit of 95 % CI of PRR was 3.01 and 1.62, PRR was 36.85 and 6.38, ROR was 36.97 and 7.66, Chi square value was 355.07 and 365.29, and IC-2SD was 3.26 and 2.42 respectively for data obtained from FAERS and EV.

CONCLUSIONS

From this study we conclude that there is a strong association between Desogestrel and severe psychiatric disorders. Our study can give required information to improve understanding of this issue. We recommend healthcare professionals and regulators to study further about this drug-event pair, as severe psychiatric disorders is not yet mentioned or included in summary of product characteristics and patient leaflet.