Is there a risk for Semaglutide Misuse? Focus on the Food and Drug Administration-FDA Adverse Events Reporting System (FAERS) pharmacovigilance dataset
Semaglutide shows a higher potential for misuse compared to other GLP-1 receptor agonists based on adverse event reports, but further research is needed to confirm these findings.
Where it sits
this study against the rest of the albiglutide corpusSummary and findings
This study evaluated the misuse and abuse signals related to semaglutide compared to other GLP-1 receptor agonists and the phentermine-topiramate combination. A total of 31,542 adverse event reports were analyzed from the FDA Adverse Events Reporting System (FAERS) between January 2018 and December 2022. The study found specific reporting odds ratios for semaglutide indicating potential misuse issues.
Abstract
Recent media reports commented about a possible antidiabetics’ misuse issue related to molecules promoted as a weight-loss treatment in non-obese people. We here evaluated available pharmacovigilance misuse/abuse signals related to semaglutide, a glucagon-like peptide-1 (GLP-1) analogue, in comparison to other GLP-1 receptor agonists (albiglutide; dulaglutide; exenatide; liraglutide; lixisenatide; tirzepatide) and the phentermine-topiramate combination. To that aim, we analysed the Food and Drug Administration-FDA Adverse Events Reporting System (FAERS) dataset, performing a descriptive analysis of adverse event reports (AER) and calculating related pharmacovigilance measures, including the reporting odds ratio (ROR) and the proportional reporting ratio (PRR). During January 2018-December 2022, a total of 31,542 AER involving the selected molecules were submitted to FAERS; most involved dulaglutide (n=11,858; 37.6%) and semaglutide (n=8,249; 26.1%). In comparing semaglutide vs the remaining antidiabetics, the AER ‘drug abuse’, ‘drug withdrawal syndrome’, ‘prescription drug used without a prescription’ and ‘intentional product use issue’ respective PRR values were 4.05, 4.05, 3.60 and 1.80 (all<0.01). The same comparisons of semaglutide vs the phentermine-topiramate combination were not associated with any significant differences. To our best, this is the first study documenting the misusing/abusing potential of semaglutide in comparison with other novel antidiabetics and the phentermine-topiramate combination. Current findings will need to be confirmed by further empirical investigations to fully understand the safety profile of those molecules.