Prescribed Drugs and Self-Directed Violence: A Descriptive Study in the Spanish Pharmacovigilance Database

Abstract

Self-inflicted violence is a major and growing public health problem and its prediction and prevention is challenging for healthcare systems worldwide. Our aim was to identify prescribed drugs associated with self-directed violent behaviors in Spain. A descriptive, longitudinal and retrospective study of spontaneous reports of adverse drug reactions corresponding to self-directed violence was recorded in the Spanish Pharmacovigilance Database (FEDRA^®) from 1984 to 31 March 2021. A total of 710 cases were reported in the study period. The mean age was 45.52 years (range 1-94). There were no gender differences except in children, where most reports were of male children. The main therapeutic groups that were involved included drugs for the nervous system (64.5%) and anti-infectives for systemic use (13.2%). The most commonly reported drugs were varenicline, fluoxetine, lorazepam, escitalopram, venlafaxine, veralipride, pregabalin, roflumilast and bupropion. There were reports of montelukast, hydroxychloroquine, isotretinoin, methylphenidate, infliximab, natalizumab, ribavirin and efavirenz, which were less known to be involved in self-directed violence. This study shows that self-directed violence is a rare adverse drug reaction, and can be related to the use of some medicines. It is important for healthcare professionals to consider this risk in their clinical praxis, implementing person-centred approaches. Further studies are needed, considering comorbidities and potential interactions.

Keywords: FEDRA®; adverse drug reactions; pharmacovigilance; self-directed violence.

Figure 1

Self-directed violence classification. * Suicide related ideations can be casual, transient, passive or persistent independent of the degree of suicidal; (a) verbal or non-verbal, passive or active; (b) a proposed method of achieving a potentially self-injurious outcome; (c) without injuries; (d) with injuries; (e) with fatal outcome.

Figure 2

Temporal evolution of reports of self-inflicted violence.

Figure 3

Number of reports according to primary sources.

Figure 4

Percentage of self-directed reports by age group.

Figure 5

Percentage of self-directed reports by age group and sex.