Antipsychotics and obsessive-compulsive disorder/obsessive-compulsive symptoms: A pharmacovigilance study of the FDA adverse event reporting system

Bradley G Burk; Tilyn DiGiacomo; Shea Polancich; Brandon S Pruett; Soumya Sivaraman; Badari Birur

doi:10.1111/acps.13567

Antipsychotics and obsessive-compulsive disorder/obsessive-compulsive symptoms: A pharmacovigilance study of the FDA adverse event reporting system

Acta Psychiatr Scand. 2023 Jul;148(1):32-46. doi: 10.1111/acps.13567. Epub 2023 May 17.

Authors

Bradley G Burk¹, Tilyn DiGiacomo², Shea Polancich^{3

4}, Brandon S Pruett^{5

6}, Soumya Sivaraman^{5

6}, Badari Birur^{5

6}

Affiliations

¹ Department of Pharmacy, University of Alabama at Birmingham Medical Center, Birmingham, Alabama, USA.
² McWhorter School of Pharmacy, Samford University, Birmingham, Alabama, USA.
³ Department of Nursing, University of Alabama at Birmingham Medical Center, Birmingham, Alabama, USA.
⁴ School of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA.
⁵ Department of Psychiatry, University of Alabama at Birmingham Medical Center, Birmingham, Alabama, USA.
⁶ Department of Psychiatry and Behavioral Neurobiology, University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, USA.

PMID: 37194481
DOI: 10.1111/acps.13567

Abstract

Objective: Antipsychotics have conflicting data with respect to obsessive-compulsive disorder/symptoms (OCD/OCS), with some reporting causality and some reporting treatment benefits. This pharmacovigilance study aimed to investigate reporting of OCD/OCS in association with the use of antipsychotics in comparison to one another, as well as treatment failure using data derived from the FDA Adverse Event Reporting System (FAERS).

Methods: Data from January 1st, 2010 to December 31st, 2020 on suspected adverse drug reactions (ADRs) including OCD/OCS was obtained. The information component (IC) was used to determine a disproportionality signal, and reporting odds ratio (ROR) calculations were performed via intra-class analyses to discern differences between the evaluated antipsychotics.

Results: A total of 1454 OCD/OCS cases were utilized in IC and ROR calculations and 385,972 suspected ADRs were used as non-cases. A significant disproportionality signal was seen with all second generation antipsychotics. Relative to other antipsychotics, only aripiprazole had a significant ROR of 23.87 (95% CI: 21.01-27.13; p < 0.0001). The ROR for antipsychotic treatment failure in those with OCD/OCS was highest with aripiprazole, and lowest with risperidone and quetiapine. Sensitivity analyses were largely in favor of the primary findings. Our analysis appears to implicate the 5-HT_1A receptor or an imbalance between this receptor and the D₂ -receptor in antipsychotic treatment-emergent OCD/OCS.

Conclusions: In contrast to prior reports noting clozapine as the antipsychotic most commonly associated with de novo or exacerbated OCD/OCS, this pharmacovigilance study found aripiprazole was most frequently reported for this adverse effect. While these findings from FAERS offer a unique perspective on OCD/OCS with different antipsychotic agents, due to the inherent limitations of pharmacovigilance studies they should ideally be validated through alternative prospective research studies involving direct comparisons of antipsychotic agents.

Keywords: FDA adverse event reporting system; antipsychotic; obsessive-compulsive disorder; pharmacovigilance; reporting odds ratio.

MeSH terms

Antipsychotic Agents* / adverse effects
Aripiprazole / adverse effects
Drug-Related Side Effects and Adverse Reactions* / epidemiology
Humans
Obsessive-Compulsive Disorder* / drug therapy
Obsessive-Compulsive Disorder* / epidemiology
Pharmacovigilance
Prospective Studies

Substances

Antipsychotic Agents
Aripiprazole