GLP-1 Vision Loss Lawsuits: NAION and the US Label Gap

The Wall Street Journal reported on 19 September 2026 that patients are suing GLP-1 drugmakers over the risk of sudden vision loss. Plaintiffs’ firms market these claims as Ozempic blindness lawsuits; in the court record they are MDL No. 3163. The label record behind that headline points the other way: non-arteritic anterior ischemic optic neuropathy — NAION — sits on semaglutide product information in the EU and in a UK safety notice, and appears nowhere on US labelling.

Does Ozempic cause vision loss?

European regulators concluded that NAION, a rare and generally irreversible — that is, permanent — loss of vision usually in one eye, is a very rare side effect of semaglutide — the ingredient in Ozempic, Wegovy and Rybelsus — at a frequency of up to 1 in 10,000, with a two-fold relative increase in risk and about one additional case per 10,000 person-years. That is a large relative increase on a small absolute base: NAION stays uncommon in people taking semaglutide, and the same medicines carry established cardiovascular and metabolic benefits. US labelling does not name NAION on any document checked for this article. This is not medical advice and not a reason to stop a prescribed medicine, and our underreported GLP-1 side effects hub explains how rare signals in this class get counted.

Where the cases stand

MDL No. 3163 — In re: GLP-1 RAs Non-Arteritic Anterior Ischemic Optic Neuropathy Products Liability Litigation (the GLP-1 NAION MDL) — was created by a Judicial Panel on Multidistrict Litigation transfer order, Doc. 49, filed 15 December 2025. It covers 21 actions pending in three districts plus nine related actions noticed to the Panel, names Ozempic, Wegovy, Saxenda and Trulicity, and recites identical failure-to-warn, design-defect and warranty claims. Eli Lilly moved under 28 U.S.C. § 1407 to centralize in the Eastern District of Pennsylvania; the Panel declined to fold the cases into the gastrointestinal-injury MDL No. 3094 and assigned them to the Hon. Karen S. Marston. Every claim is an allegation: the order makes no finding on causation or on any label’s adequacy.

On the count, use the court. The JPML’s monthly statistics report records 216 actions pending in MDL 3163 as of 1 September 2026 — an actions-pending basis, not claims or plaintiffs, and the only case count printed here. The wider legal track runs through the Fifth Circuit ruling on compounded semaglutide.

Where the labels diverge

The divergence is specific to semaglutide, and a version of the claim that does not name it is wrong for tirzepatide: EU Mounjaro product information, last updated 28 August 2026, contains no occurrence of NAION.

The US absence is not a stale-document artifact: NAION appears zero times across 13 US semaglutide and tirzepatide documents, including five FDA-hosted label PDFs, five DailyMed entries and the openFDA label records. In the EU product information it appears 17 times for Ozempic, 22 for Wegovy and 18 for Rybelsus, under a section 4.4 subsection headed “Non-arteritic anterior ischaemic optic neuropathy (NAION)”. The UK notice makes the same scoping point: other GLP-1 agonists were outside its review.

How the warning reached Europe

The EMA committee concluded on 6 June 2025 that NAION is a very rare side effect of semaglutide and recommended a product-information update; WHO followed with a medical product alert on 27 June 2025. The MHRA Drug Safety Update of 5 February 2026 reports three spontaneous Yellow Card reports suggestive of NAION with semaglutide between 2018 and 1 August 2025, against 10.2 million packs dispensed in five years, and tells clinicians to refer urgently and discontinue if NAION is confirmed. Three reports is a signal rather than a proven cause — the same evidentiary shape as the 15 reported cases of Wernicke encephalopathy in GLP-1 users. Denmark’s compensation body dates the EU label change to 2 October 2025, when NAION entered the side-effect section for Wegovy, Ozempic and Rybelsus.

What the FDA has said

On the FDA surfaces checked on 19 September 2026 — the Drug Safety Communications index, label text and advisory-committee surfaces — there is no NAION safety communication and no announced NAION label change. The only GLP-1 entry on that index in the same window, dated 13 January 2026, removes a suicidal-ideation warning instead.

What this means if you take a GLP-1

None of this changes a prescription. Do not stop a prescribed GLP-1 on the strength of a news story or a lawsuit count; that is a conversation with the prescriber who knows the indication, the dose and the history. Stopping is common regardless, and who stops semaglutide and what happens next covers what the registry data show. Other side-effect questions keep arriving — the 2026 NYU and Penn hair-loss studies are the latest — and general questions are answered in our peptide FAQ.

Sources

1. JPML, MDL No. 3163 transfer order, Doc. 49, filed 15 December 2025 — court primary.
2. E.D. Pa., MDL 3163 page and orders index — court primary.
3. JPML, Pending MDL Dockets by Actions Pending, 1 September 2026 — court primary; the 216-action row.
4. EMA, Ozempic product information, EPAR, last updated 25 August 2026 — regulator primary.
5. MHRA Drug Safety Update: semaglutide and NAION, published 5 February 2026 — regulator primary.
6. EMA news: PRAC concludes NAION is a very rare side effect of semaglutide, 6 June 2025, revised 13 June 2025 — regulator primary.
7. WHO medical product alert: semaglutide medicines and NAION, 27 June 2025 — regulator primary.
8. Patienterstatningen, first compensation decisions, 21 November 2025 — regulator primary; Danish compensation decisions, not a causation finding.
9. FDA Drug Safety Communications index — regulator primary; content current as of 15 September 2026.
10. DailyMed SPLs and the openFDA label records for the five US products — regulator primary.
11. The Wall Street Journal, “Patients Sue GLP-1 Drugmakers Over Risk of Sudden Vision Loss”, 19 September 2026, seen through an aggregator feed — headline and date only; the article body was not read, and nothing here is attributed to its contents.

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