Eli Lilly strengthens safety monitoring for Mounjaro and Zepbound
Eli Lilly reinforces safety monitoring for GLP-1 drugs amid vision loss litigation and international regulatory warnings.
Event / Health
GLP-1 Drug Safety Litigation
Multiple lawsuits filed against GLP-1 manufacturers alleging inadequate warnings about potential vision loss risk (NAION). FDA conducting ongoing safety review with mixed scientific evidence. European and Australian regulators have mandated warnings while US FDA continues evaluation. Risk estimated at 1 in 10,000 for diabetic users.
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4 articles0 articles
2026-09-22 to 2026-11-03 · UTC publication dates
Coverage begins 22 Sept, 07:26 UTC
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What happened
Novo Nordisk defends GLP-1 drugs against personal injury lawsuits
Novo Nordisk, manufacturer of Ozempic and Wegovy, stated that personal injury lawsuits filed in the United States are without merit and committed to vigorously defending them. The company stated it takes all adverse event reports seriously and continuously monitors the safety profile of its GLP-1 products.
Multiple scientific studies show mixed results on GLP-1 and NAION link causation
Since the initial 2024 Boston health system research, larger studies have produced mixed results regarding whether a causal link exists between GLP-1 drug use and NAION. No study to date has conclusively proven that these medications cause the eye condition, though several studies suggest a potential association exists.
European Medicines Agency estimates NAION could affect 1 in 10,000 GLP-1 users with diabetes
Based on analysis of available information, the European Medicines Agency estimates that the eye condition NAION could possibly impact approximately 1 out of every 10,000 GLP-1 users who have diabetes, representing a rare but quantifiable potential risk.
Eli Lilly reaffirms commitment to monitoring safety of GLP-1 medications Mounjaro and Zepbound
Eli Lilly, manufacturer of Mounjaro and Zepbound, emphasized that patient safety is its top priority and that it actively monitors and reports safety information to the FDA. The company stated it has ongoing discussions with regulators regarding potential safety topics and will continue reviewing data related to ophthalmic issues.
Dozens of Americans filed personal injury lawsuits against GLP-1 drug makers over vision loss risks
Multiple Americans filed personal injury lawsuits against manufacturers of popular GLP-1 drugs including Ozempic, Wegovy, and Mounjaro. The lawsuits allege that drug makers failed to adequately warn patients about the risk of nonarteritic anterior ischemic optic neuropathy (NAION), a rare form of sudden vision loss associated with use of these medications.
FDA has ongoing review of potential GLP-1 drug safety signal related to vision loss
The Food and Drug Administration's Sentinel Initiative is conducting a scientific review to evaluate the possible safety signal related to GLP-1 drugs and NAION. The review remains ongoing and the FDA does not currently require drug makers to list NAION as a specific risk on product labeling, though vision problems are listed as possible side effects.
European Medicines Agency and Australia require NAION warnings on GLP-1 drug labels
The European Medicines Agency and Australia's Therapeutic Goods Administration have required drug manufacturers to include warnings about a possible increased risk of developing NAION when taking certain GLP-1 medications. These regulatory bodies cited NAION as a rare possible side effect based on their review of available evidence.
Boston health center reported possible safety signal linking GLP-1 drugs to vision loss in 2024
Researchers at a single health system in Boston published data in 2024 suggesting a possible link between GLP-1 receptor agonists like semaglutide and increased risk of NAION (nonarteritic anterior ischemic optic neuropathy) in patients with type 2 diabetes. This safety signal prompted subsequent research but no study has yet proven direct causation.
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2 alternative perspectives
EMA and Australia mandate NAION warnings on GLP-1 drug labels
EMA and Australia require GLP-1 manufacturers to add NAION warnings, affecting an estimated 1 in 10,000 diabetic users.
FDA continues review of GLP-1 vision loss safety signal
FDA reviews potential GLP-1 vision loss signal amid mixed scientific findings on causation.
Dozens sue GLP-1 makers over alleged vision loss risks
Plaintiffs sue GLP-1 makers for vision loss; manufacturers deny liability.