Ozempic lawsuit: where the Wegovy, Mounjaro, Zepbound and GLP-1 cases stand

No U.S. label, FDA page or European product information read for this page lists muscle loss, lean-mass loss or sarcopenia as a side effect, an adverse reaction or a warning for any of these drugs.

Two U.S. labels mention lean mass, and both do it in section 12.2, headed Pharmacodynamics, which sits under the label's clinical pharmacology and not under its warnings or its adverse reactions. Wegovy's reads: “Semaglutide lowers body weight with greater fat mass loss than lean mass loss.” Zepbound's reads: “Tirzepatide lowers body weight with greater fat mass loss than lean mass loss.”

The other six labels (Ozempic, Rybelsus, Victoza, Saxenda, Trulicity and Mounjaro) do not contain the words lean mass or sarcopenia, and the only place any of them uses the word muscle is in the injection instructions, which say not to inject into one.

In Europe, the product information for Wegovy and Mounjaro describes body composition in section 5.1 of each, Pharmacodynamic properties, as a result measured in a clinical trial. Wegovy's: “The results of the DEXA assessment showed that treatment with semaglutide was accompanied by greater reduction in fat mass than in lean body mass leading to an improvement in body composition compared to placebo after 68 weeks.” Mounjaro's: “The results of the DEXA assessment showed that treatment with tirzepatide was accompanied by greater reduction in fat mass than in lean body mass leading to an improvement in body composition compared to placebo after 72 weeks.” Both sentences report what a trial measured across its participants. Neither says how much lean mass any one person loses, and nothing on this page estimates that.

At the FDA, none of the 23 quarterly lists of potential safety signals read for this page has a row for GLP-1 drugs about muscle or lean mass, and none of the Drug Safety Communications on the FDA's list is about it.

The court's words on the subject describe what the plaintiffs allege. Its memorandum of August 15, 2025 in MDL No. 3094 introduces the plaintiffs' list this way: “They allege GLP-1 RAs can and have caused a “myriad of injuries” including:” Among the items is “Micronutrient disease, which can lead to muscle wasting and Wernicke’s Encephalopathy”. The court then says: “For ease of reference, the Court refers to these injuries collectively as the “Alleged Injuries.”” That is the court describing what the plaintiffs claim, not a finding about what any drug does.

All eight U.S. labels carry a warning headed Acute Pancreatitis: section 5.2 in Ozempic, Rybelsus, Wegovy, Victoza, Saxenda, Trulicity and Mounjaro, and section 5.5 in Zepbound.

Ozempic's opens: “Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including OZEMPIC”. Among the reports received after approval, in section 6.2, its label lists “acute pancreatitis and necrotizing pancreatitis, sometimes resulting in death”. Zepbound's label tells prescribers: “If pancreatitis is suspected, discontinue ZEPBOUND and initiate appropriate management.”

An FDA communication about pancreatitis dated March 14, 2013 is not about Ozempic, which it does not name. Its title: “FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes”. It lists the drugs it covers: “Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto).” Of the eight brands on this page, it names only Victoza. And it says: “FDA has not reached any new conclusions about safety risks with incretin mimetic drugs.”

The FDA no longer serves that communication at its address, which answered Page Not Found when checked on September 27, 2026. It was read from the Internet Archive's copy of the FDA's page dated December 24, 2024, which the sources below link to.

The European product information for Ozempic says, in section 4.4 on special warnings: “Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. Patients should be informed of the characteristic symptoms of acute pancreatitis.”

In the lawsuits, necrotizing pancreatitis is among what the plaintiffs claim. The court's memorandum of August 15, 2025 says that “each Plaintiff claims they were prescribed one or more of the eight identified medications for the treatment of type 2 diabetes and/or chronic weight management and that as a result, they suffered gastrointestinal symptoms and/or injuries, such as “debilitating cyclical vomiting,” gastroparesis, ileus, intestinal obstruction, gallbladder injury, vitamin deficiency, Wernicke’s Encephalopathy, ischemic bowel, and necrotizing pancreatitis.” The Short Form Complaint the court entered with Case Management Order No. 27 lists “Necrotizing Pancreatitis” among the injuries a plaintiff may check, and the checker above answers for it.

All eight U.S. labels carry a warning headed Acute Kidney Injury Due to Volume Depletion: section 5.5 in Rybelsus, Wegovy, Victoza, Trulicity and Mounjaro, section 5.6 in Ozempic and Saxenda, and section 5.3 in Zepbound.

Ozempic's section 5.6 reads “There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with semaglutide.” and goes on: “The majority of the reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea”.

The European product information for Ozempic makes the same link in section 4.4, warning that “nausea, vomiting, and diarrhoea may cause dehydration, which in rare cases can lead to a deterioration of renal function”.

Beyond the labels' warning about dehydration, the FDA material read for this page adds nothing on the kidneys: none of the 23 quarterly signal lists has a row for GLP-1 drugs about them, and none of the Drug Safety Communications on the FDA's list is about them.

Kidney injury is not on the court's list of alleged injuries in its memorandum of August 15, 2025; the July 2024 fact sheet lists “Acute Kidney Injury” among the injuries a plaintiff may report, without the labels' link to dehydration, and a form is not a ruling on what an MDL covers.

All eight U.S. labels carry a warning headed Pulmonary Aspiration During General Anesthesia or Deep Sedation: section 5.9 in Rybelsus, Victoza, Saxenda, Trulicity, Mounjaro and Zepbound, and section 5.10 in Ozempic and Wegovy.

Ozempic's reads: “There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.” On what could be done about it, the label says: “Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking OZEMPIC, including whether modifying preoperative fasting recommendations or temporarily discontinuing OZEMPIC could reduce the incidence of retained gastric contents.” And it tells prescribers: “Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking OZEMPIC.”

So the label sets no timetable for a procedure. It says the data are not enough to know whether changing the fasting rules, or the medicine, would help.

The FDA's quarterly signal list for July to September 2023, which reads “Content current as of: 04/02/2026”, records for GLP-1 drugs: “The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated between October 2024 and November 2024 to include information about aspiration during general anesthesia or deep sedation.” It adds: “FDA required a postmarketing requirement (PMR) trial in November 2024 to measure the effects of temporary withholding of GLP-1 receptor agonists and fasting duration on retained gastric contents to evaluate delayed gastric emptying  associated with GLP-1 receptor agonist use and inform potential recommendations to mitigate the serious risk of pulmonary aspiration.”

The European Medicines Agency's safety committee reported on July 12, 2024: “The committee could not establish a causal association between GLP-1 analogues and aspiration, but because of the known action of delayed gastric emptying and the presence of clinical trial cases and post marketing cases, the PRAC considered that healthcare professionals and patients should be informed on this potential consequence of delayed gastric emptying.” It said the product information would carry “a warning to patients that they should inform the doctor involved if they take these medicines and are scheduled to undergo surgery under anaesthesia or deep sedation”.

In the lawsuits, the court's memorandum of August 15, 2025 lists “Intraoperative aspiration” among the injuries the plaintiffs allege, and the Short Form Complaint lists “Aspiration”. Questions about a medicine before a procedure are for the doctor who prescribed it and the team doing the procedure.

In a Drug Safety Communication its page dates 01-13-2026, the FDA said: “FDA is requesting that drug application holders remove information regarding the risk of suicidal ideation and behavior (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications that currently include such language.” “The affected products are Saxenda (liraglutide), Wegovy (semaglutide), and Zepbound (tirzepatide).” Its review, it said, “found no increased risk of SI/B associated with the use of GLP-1 RA medications.”

Wegovy, Saxenda and Zepbound each list Suicidal Behavior and Ideation under Recent Major Changes in their labels, marked “(Removed) 02/2026”. The other five labels (Ozempic, Rybelsus, Victoza, Trulicity and Mounjaro) do not contain the word suicidal.

The FDA's own pages give two dates for the earlier communication. The 2026 one opens: “This information is an update to the FDA Drug Safety Communication: Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity issued on January 30, 2024.” The page of that earlier communication, headed “Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity”, prints the date 01-11-2024. This page does not decide which date is right. That earlier communication said: “Our preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions.”

One FDA page has not caught up. Its quarterly signal list for July to September 2023, which reads “Content current as of: 04/02/2026”, still shows, for GLP-1 drugs and suicidal ideation: “FDA is evaluating the need for regulatory action.”

In Europe, the EMA's safety committee announced on April 12, 2024: “The PRAC has concluded that the available evidence does not support a causal association between the Glucagon-Like Peptide-1 receptor agonists (GLP-1)”, which it named as “dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide”, “and suicidal and self-injurious thoughts and actions.” The sentence is quoted in three parts, around its list of names. Those are five active substances. Tirzepatide, the active ingredient in Mounjaro and Zepbound, is not one of them and is not mentioned on the agency's page, so the conclusion says nothing about tirzepatide either way.

The European product information for the seven brands read does not contain the word suicidal, and the court's list of alleged injuries in its memorandum of August 15, 2025 does not include suicidal thoughts.

No U.S. label read for this page mentions a blood clot, deep vein thrombosis, venous thromboembolism or pulmonary embolism, and none of the seven European product-information documents contains the words thrombosis or embolism. No label and no regulator read for this page names a clot as a risk of these drugs.

At the FDA, none of the 23 quarterly lists of potential safety signals read for this page has a row for GLP-1 drugs about clots or embolism, and none of the Drug Safety Communications on the FDA's list is about them.

The court has written about them in a footnote to its memorandum of October 17, 2024 in MDL No. 3094: “The Court has stayed two individual cases in which the plaintiffs allegedly suffered veinous thromboembolisms after using one of the identified GLP-1 RAs.” “The parties are currently seeking permission from the JPML to include these and similar cases in this MDL.” “At this time, however, the MDL is limited to cases alleging gastrointestinal injuries.” The spelling veinous is the court's.

Those are cases the court stayed, not cases in the MDL. The Panel later refused to add DVT injuries to MDL No. 3094, in its order of December 12, 2024: “Further expansion of MDL No. 3094 to include claims for new types of injuries would significantly complicate the management of this litigation.” “Accordingly, transfer of Craig is not warranted.”

No U.S. label read for this page mentions Wernicke’s encephalopathy, thiamine or a micronutrient deficiency, and none of the seven European product-information documents mentions Wernicke’s encephalopathy, thiamine or any vitamin.

At the FDA, none of the 23 quarterly lists of potential safety signals read for this page has a row for GLP-1 drugs about Wernicke’s encephalopathy or thiamine, and none of the Drug Safety Communications on the FDA's list is about it.

It appears in the court's words only as part of what the plaintiffs allege. The memorandum of August 15, 2025 says that “each Plaintiff claims they were prescribed one or more of the eight identified medications for the treatment of type 2 diabetes and/or chronic weight management and that as a result, they suffered gastrointestinal symptoms and/or injuries, such as “debilitating cyclical vomiting,” gastroparesis, ileus, intestinal obstruction, gallbladder injury, vitamin deficiency, Wernicke’s Encephalopathy, ischemic bowel, and necrotizing pancreatitis.” Its list of alleged injuries includes “Micronutrient disease, which can lead to muscle wasting and Wernicke’s Encephalopathy”, and a footnote describes the condition, quoting the plaintiffs' complaint: “Wernicke’s Encephalopathy is “a life-threatening degenerative brain disorder caused by the lack of vitamin B1,” also known as thiamine, “and is characterized by mental confusion, vision problems, coma, hypothermia, low blood pressure, and ataxia (or lack of muscle coordination).””

A second memorandum filed the same day, August 15, 2025, repeats that plaintiffs claim “they suffered gastrointestinal symptoms and/or injuries, such as “debilitating cyclical vomiting,” gastroparesis, ileus, intestinal obstruction, gallbladder injury, vitamin deficiency, Wernicke’s Encephalopathy, ischemic bowel, and necrotizing pancreatitis.” The Short Form Complaint lists “Wernicke’s encephalopathy” among the injuries a plaintiff may check.