EudraVigilance review finds off-label use dominates tirzepatide safety reports
Off-label use was the most common preferred term with 1,521 reports, while 'drug ineffective' reporting odds were lower for tirzepatide than for five other GLP-1 agonists.
DO
By Daniel Okafor · Regulatory Correspondent
Sep 30 20:00 ETSource: BMJ open
The wire
- 01A retrospective disproportionality analysis of EudraVigilance individual case safety reports found 'off-label use' (n=1,521), 'drug ineffective' (n=425) and 'off-label use of device' (n=99) as the leading tirzepatide preferred terms.
- 02Tirzepatide showed lower reporting odds of ineffectiveness than liraglutide, dulaglutide, exenatide and semaglutide, though among healthcare-professional reports it did not differ from semaglutide.
- 03Spontaneous reporting cannot establish incidence or causality, and the authors caution on the very wide confidence interval for off-label device use versus semaglutide (ROR 43.47, 16.00-118.13).
From the source
Read at pubmed.ncbi.nlm.nih.govTirzepatide safety in EudraVigilance: descriptive and disproportionality analysis of preferred terms related to suboptimal treatment outcomes and drug-use-related issues
BMJ open · 2026 Oct 1 · Popa Ilie IR, Ghibu S, Butuca A et al.
Source URL https://pubmed.ncbi.nlm.nih.gov/42823110/
