In FAERS reports, semaglutide had higher muscle-atrophy reporting odds than all other drugs (ROR 2.39, 95% CI 1.63-3.52).
In plain wordsSemaglutide had higher muscle-atrophy reporting odds than all other drugs in FAERS.
- Peptide
- Semaglutide
- Outcome
- IncreaseMuscle atrophy reporting
- Study
n: not reported in source
- Comparator
- All other drugs in FAERS
- Outcome group
- Adverse events · Musculoskeletal
- Studied dose
- Dose not stated
Measurements
- Reporting odds ratio
- 2.39
- muscle atrophy versus all other FAERS drugs; 95% CI 1.63-3.52
Source sentences
Disproportionality analysis showed pharmacovigilance signals for semaglutide (ROR = 2.39, 95 % CI = 1.63-3.52) and tirzepatide (ROR = 1.69, 95 % CI = 1.14-2.50), indicating increased reporting of muscle atrophy relative to all other drugs in FAERS.
4 context sentences(design, population, supporting numbers)
MethodsWe analyzed reports of muscle atrophy submitted to the FDA Adverse Event Reporting System (FAERS) database from October 2003 to March 2024 using the validated pharmacovigilance tool OpenVigil 2.1.
Disproportionality was assessed using reporting odds ratios (RORs) with 95 % confidence intervals (CIs), the standard metric for pharmacovigilance signal detection worldwide.
To contextualize associations, disproportionality estimates were calculated using niacin, simvastatin, and the complete FAERS database (all other drugs) as comparators.
ResultsA total of 142 cases of muscle atrophy were identified with GLP-1 RA therapy, the majority occurring in adults aged 18-64 years (43 % female, 57 % male).