US Lawsuits Target GLP-1 Drugmakers Over Rare Vision Loss Risk
Dozens in the US sue Novo Nordisk and Eli Lilly over alleged failure to warn about a rare eye condition; both firms deny the claims.
Dozens of people in the United States have filed personal injury lawsuits against the makers of widely used GLP-1 medicines, including Ozempic, Wegovy and Mounjaro, alleging they were not properly warned about a rare form of sudden vision loss.
The condition, nonarteritic anterior ischemic optic neuropathy (NAION), affects the optic nerve and can cause abrupt, painless loss of sight. Researchers have been looking into a possible link between GLP-1 drugs and NAION, but no study has so far established that the medicines cause the condition.
A potential safety signal first emerged in 2024 after observations at a single health centre in Boston. Since then, researchers and regulators have continued to assess whether a connection exists.
Drugmakers push back
Novo Nordisk, which makes Ozempic and Wegovy, said it treats all reports of adverse events with seriousness but rejected the allegations. The company said it believes the US lawsuits are without merit and is defending them vigorously, adding that it monitors the safety profile of its GLP-1 receptor agonist products and will act if emerging data warrant it.
Eli Lilly, which makes Mounjaro and Zepbound, said patient safety is its top priority and that it actively monitors, evaluates and reports safety information to the FDA. It said it holds routine discussions with regulators on potential safety topics and will keep reviewing data, including any relating to eye issues.
FDA review ongoing
Vision problems already feature among the possible side effects of these medicines, though the US Food and Drug Administration does not currently require manufacturers to name NAION specifically on labels. The agency's Sentinel Initiative is carrying out a review of the possible safety signal, which remains under way. The FDA said it routinely monitors postmarketing safety, evaluates available data and takes regulatory action when appropriate.
Divergent global stance
Some regulators abroad have taken a different view of the evidence. The European Medicines Agency and Australia's Therapeutic Goods Administration have both required drugmakers to add warnings about a potentially increased risk of NAION with certain GLP-1 medicines, describing the condition as a rare possible side effect.