3 stories
Drug-safety coverage on Peptide News Digest is the FAERS-side cross-section: post-market AE reports, label updates, MDL litigation, and comparative safety analyses across approved drugs.
Key threads in 2025 and 2026: the Ozempic MDL (3,363 cases over alleged gastroparesis and other injuries before Judge Karen Marston in EDPA, with critical Daubert and summary judgment deadlines in late April 2026), Medscape FAERS analyses showing different AE profiles across GLP-1 drugs, NAION optic-neuropathy signals, and the qualitative literature on emotional side effects of weight loss.
Stories here cover FAERS signals, label updates, and litigation. See #safety, #peptide-safety, and #litigation.
BioSpace analysis frames the ACHIEVE-4 results as a direct answer to the FDA's April 1 letter requesting post-market liver injury and cardiovascular data. The 'outstanding' type 2 diabetes data, combined with cardiovascular safety and all-cause death reductions, strengthens Lilly's position ahead of its Q2 FDA submission and could reduce regulatory friction for the oral GLP-1 franchise.
The FDA asked Eli Lilly for additional safety data on liver injury linked to Foundayo (orforglipron), plus post-marketing trials to assess cardiovascular event risk and delayed gastric emptying. A lactation study was also required. The letter, signed April 1, was published April 14 — just two weeks after the drug's fast-track approval under the National Priority Voucher program.
Analysis of the FAERS database (2012–2025) examining exenatide, liraglutide, dulaglutide, semaglutide, and tirzepatide reveals distinct risk profiles, suggesting not all GLP-1 agents carry the same safety concerns.