Understanding senna risks: Evidence from the FDA adverse event reporting system.

Area of Science:

• Pharmacovigilance and Herbal Medicine Safety
• Clinical Pharmacology
• Drug Safety Surveillance

Background:

• Senna, a widely used leguminous medicinal plant, possesses traditional therapeutic properties including laxative effects.
• Despite its common use, the safety profile and potential adverse events (AEs) of senna are not fully understood.
• Pharmacovigilance data is crucial for evaluating the safety of herbal remedies like senna.

Purpose of the Study:

• To analyze senna-related adverse events (AEs) reported in the FDA Adverse Event Reporting System (FAERS) database from 2004 to 2024.
• To evaluate the strength of evidence for these AEs and identify potential risk factors.
• To assess the causal relationship between senna use and reported adverse events.

Main Methods:

• Analysis of over 18 million senna-related reports from the FAERS database.
• Disproportionality analyses using ROR, PRR, IC, and EBGM algorithms.
• Logistic regression and time-to-onset analysis for risk factor identification; modified Bradford Hill criteria for causality assessment.

Main Results:

• A significant increase in reported AEs was observed, with immune system disorders being the most frequent System Organ Class (SOC).
• Females (62.86%) and individuals over 60 years (32.09%) were most affected, with a median onset of 4 days.
• Advanced age, female sex, and concomitant use of ascorbic acid and tofacitinib citrate were identified as risk factors for immune system disorders.

Conclusions:

• Senna use is potentially linked to immune system disorders, necessitating careful clinical monitoring.
• The findings suggest a plausible causal relationship based on modified Bradford Hill criteria.
• Further investigation into the mechanisms of senna-induced adverse reactions is warranted.