Comparison of ileus risk in selected second-generation antipsychotics based on FAERS database

Area of Science:

• Pharmacovigilance
• Clinical Pharmacology
• Gastroenterology

Background:

• Second-generation antipsychotics (SGAs) offer an alternative to older drugs with potentially fewer side effects.
• Clinical observations have suggested a link between SGA use and the development of ileus.
• Ileus, a condition characterized by the cessation of intestinal motility, poses significant health risks.

Purpose of the Study:

• To investigate the association between second-generation antipsychotics (SGAs) and the occurrence of ileus.
• To quantify the risk of ileus associated with SGA use using pharmacovigilance data.
• To identify specific SGAs that may pose a higher risk for ileus.

Main Methods:

• A pharmacovigilance analysis was conducted using U.S. Food and Drug Administration Adverse Event Reporting System data from 2014 to 2023.
• Descriptive statistics were used to summarize patient demographics, reaction outcomes, and drug actions.
• Disproportionality analysis, employing Reporting Odds Ratio (ROR) and Information Component (IC) algorithms, was used for risk signal detection.

Main Results:

• A total of 419 cases of SGA-related ileus were identified.
• The median age of affected patients was 58 years, with a median onset time of 40 days.
• Clozapine demonstrated the strongest risk signal for ileus (ROR$_{0.25}$=2.77, IC$_{0.25}$=1.42), while risperidone did not show a significant association (ROR$_{0.25}$=0.68, IC$_{0.25}$=-0.38).

Conclusions:

• The study suggests that administration of second-generation antipsychotics is associated with an increased risk of ileus.
• These findings underscore the importance of monitoring for ileus in patients treated with SGAs.
• The results provide valuable insights for the safe and effective use of SGAs, particularly highlighting clozapine as a potential risk factor.