Suspected adverse reactions to medications and food supplements containing Serenoa repens: A worldwide analysis of pharmacovigilance and phytovigilance spontaneous reports

Abstract

AbstractThe safety of Serenoa repens (SR)‐containing products was evaluated conducting a retrospective worldwide analysis of pharmaco‐ and phytovigilance report forms of suspected adverse reactions (SARs) collected up to 31 January 2022. Multivariate logistic regression was performed to estimate the odds ratios (ORs) of serious SAR. A total of 1810 report forms were analysed; 92% of subjects were males, with a median age of 69 years; 44% of cases were defined as serious. Subjects exposed to dietary supplements had a higher risk of developing serious SARs (OR: 1.60 [95% CI: 1.20–2.15]), as subjects exposed to 2–5 (OR: 1. 83 [95% CI: 1.30–2.58]) or more than 5 (OR: 3.45 [95% CI: 2.36–5.06]) suspect/interacting products. The probability of experiencing serious SAR was higher for subjects exposed to concomitant products (OR: 1.55 [95% CI: 1.15–2.08]), to more than four active compounds (OR: 4.38 [95% CI: 3.21–5.99]) and to SR for more than 14 days (OR: 1.89 [95% CI: 1.10–3, 22]), and lower for subjects exposed to higher doses of SR (OR: of 0.34 [95% CI: 0.20–0.58]). This evidence improves awareness on safety of SR containing products, suggesting the need of a further update of periodic reviews by national and international regulatory agencies.