Semaglutide shows significant association with alopecia and reproductive disorders in pharmacovigilance analysis

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) like semaglutide are highly effective treatments for type 2 diabetes and obesity, offering significant benefits in glycemic control and weight loss. While their metabolic effects are well-documented, a comprehensive understanding of all potential adverse events, particularly less common ones like alopecia or hormonal imbalances, is crucial for patient safety and adherence. This study addresses a gap in the safety profile by investigating the association between GLP-1 RAs and these specific adverse events, which can significantly impact patients' quality of life.

Researchers conducted disproportionality analyses using the VigiBase database, a global repository of individual case safety reports. The study examined 7 GLP-1 Receptor Agonists (GLP-1-RAs), including semaglutide, dulaglutide, liraglutide, exenatide, lixisenatide, albiglutide, and tirzepatide, for 7 specific alopecia-related adverse events (AEs) as defined by the MedDRA system. Additionally, reproductive and endocrine-related AEs were investigated. The analysis calculated adjusted Reporting Odds Ratios (aRORs) to identify significant associations between these GLP-1-RAs and the specified adverse events, comparing their reporting frequency against all other drugs in the database.

The disproportionality analysis identified a total of 1276 alopecia-related cases and 759 reproductive or endocrine-related cases associated with GLP-1-RAs within the VigiBase database. Specifically, semaglutide demonstrated a significant positive association with alopecia, showing an adjusted Reporting Odds Ratio (aROR) of 1.23 (95% CI: 1.11-1.35). This indicates that alopecia was reported 23% more frequently with semaglutide compared to other drugs. > Notably, semaglutide also exhibited a strong positive association with reproductive/hormonal disorders, including polycystic ovary syndrome (PCOS), with an aROR of 6.59 (95% CI: 3.73-11.64). This suggests a nearly 6.6-fold higher reporting rate for these conditions with semaglutide. While other GLP-1-RAs were included, semaglutide showed the most prominent signals for these specific adverse events, highlighting a potential drug-specific effect within the class.