(C-187) Turn me on! Turn me off! Sexual Dysfunctions as Adverse Drug Reactions of Antipsychotic Medications

Background: Antipsychotics are used to treat mental health disorders, such as psychosis, by blocking dopamine receptors in the brain. Sexual dysfunction linked to antipsychotics is highly prevalent, exceeding 50% in some cases, with a higher prevalence in women.

Objectives: This study aims to analyze the types of sexual dysfunctions reported as suspected adverse drug reactions (ADRs) to antipsychotic medications submitted to the European pharmacovigilance system.

Methods: A retrospective analysis was conducted on ADRs cases submitted to the EudraVigilance (EV) database in the context of post-marketing surveillance. The inclusion criteria for cases were as follows: 1) an EV Gateway Date between January 1, 2014, and December 31, 2023; 2) involvement of a medicinal product classified as suspect, categorized under the Anatomical Therapeutic Chemical N05A Antipsychotics group; 3) reporting of at least one ADR classified under the Standardized MedDRA Query for Sexual Dysfunction (narrow search) or under the MedDRA High Level Term Sexual Desire Disorders. Identified MedDRA Preferred Terms (PTs) were grouped into five categories of sexual dysfunction: desire, arousal, orgasm, sexual pain, and other. Descriptive statistics were used for data analysis.

Results: We identified 3,589 cases meeting the inclusion criteria, with most involving males (n=2,578; 71.9%) and individuals aged 18–64 years (n=2,126; 59.5%). The most frequently reported PTs were erectile dysfunction (n=1,010; 28.0%), followed by sexual dysfunction (n=942; 26.2%) and compulsive sexual behavior (n=666; 18.6%). Regarding sexual dysfunction categories, arousal dysfunction was more frequently reported in men (n=1,030; 40.0%), while desire dysfunction was the most common in women (n=615; 71.1%). Among the antipsychotics reported as suspected in male cases, the most frequently reported was aripiprazole (n=845; 32.8%), followed by paliperidone (n=638; 24.7%) and risperidone (n=543; 21.1%). In female cases, aripiprazole was the most reported (n=561; 64.9%), followed by quetiapine (n=149; 17.3%) and risperidone (n=138; 16.0%). Erectile dysfunction, the most reported sexual dysfunction in men, was most frequently associated with paliperidone (n=310; 31.7%), while in women, compulsive sexual behavior was linked to aripiprazole in nearly all cases.

Conclusions: While sexual disorders are more prevalent in women, more than two-thirds of the reports in our study pertain to men, which may reflect cultural factors related to the discussion of sexual health. These results highlight the importance of considering these ADRs when selecting treatment, emphasizing a collaborative approach between clinicians and patients to minimize health impacts and promote therapeutic adherence.