Peptide Safety News

An analysis suggests GLP-1 receptor agonist drugs show no strong signal of psychiatric harm, though one unexplained finding warrants continued monitoring. The reassurance matters given wide patient exposure and prior concerns about mood effects. Clinicians are advised to remain vigilant for rare or subgroup-specific neuropsychiatric events.

Law firm Parker Waichman LLP has filed multiple lawsuits alleging patients developed NAION, an irreversible eye condition causing permanent vision loss, after taking Novo Nordisk's semaglutide drugs Ozempic and Wegovy. The lawsuits cite research linking semaglutide to increased NAION risk. The litigation alleges the manufacturer failed to adequately warn about the eye-injury risk.

Law firm Parker Waichman has filed multiple lawsuits alleging that patients developed NAION, a rare and irreversible optic nerve condition causing permanent vision loss, after taking Novo Nordisk's semaglutide drugs Wegovy and Ozempic. A Massachusetts plaintiff's suit was filed on June 5, 2026. The claims cite studies, including one in JAMA Ophthalmology and Mass Eye and Ear research, suggesting increased NAION risk among semaglutide users. The litigation alleges the manufacturer failed to adequately warn about the risk.

Despite FDA resolution of GLP-1 drug shortages, compounded (non-FDA-approved) versions of semaglutide and tirzepatide remain widely sold through clinics and medical spas. Data presented at the Obesity Medicine Association annual meeting show some suppliers have inconsistent licensure or FDA disciplinary action. Researchers highlight ongoing safety and quality concerns with compounded GLP-1s.

A cross-sectional analysis of the FDA FAERS database indicates that while cutaneous adverse events associated with GLP-1 receptor agonists are statistically rare, they do occur. The most frequently reported reactions included rash, pruritus, and injection site reactions. Researchers suggest that switching from daily to weekly formulations may mitigate these skin-related side effects in sensitive patients.

A systematic review and network meta-analysis of 39 studies (33,354 participants) assessed gastrointestinal adverse events of GLP-1 receptor agonists in non-diabetic patients with overweight or obesity. Nausea, vomiting, diarrhea, and constipation were the most common side effects. Orforglipron showed the highest nausea risk, followed by exenatide, tirzepatide, semaglutide, and liraglutide. The differing safety profiles can help clinicians tailor weight-loss therapy choices.

Novo Nordisk has filed 14 new lawsuits against telehealth companies and medical spas for distributing unapproved compounded versions of semaglutide. The company alleges these entities are violating laws regarding the corporate practice of medicine and using illicit ingredients to create 'knockoff' versions of Wegovy and Ozempic. This expands the company's total litigation to 132 cases across 40 states aimed at removing unsafe alternatives from the market.

Novo Nordisk has severed ties with Hims & Hers Health, Inc. after just one month, citing the telehealth company's continued sale of 'illegitimate, knockoff' compounded semaglutide products. The pharmaceutical giant alleges that Hims & Hers engaged in deceptive marketing and illegal mass compounding, which puts patients at risk by using unregulated, potentially foreign-sourced ingredients. This move follows the FDA's recent resolution of the Wegovy shortage, allowing Novo Nordisk to strictly enforce the use of its FDA-approved medication over unauthorized alternatives.

In April 2025 Pfizer discontinued development of the oral GLP-1 receptor agonist danuglipron for chronic weight management after late-stage trials revealed a drug-induced liver injury (DILI) signal with elevated liver enzymes. The decision ended a years-long effort to field a small-molecule GLP-1 pill and came after an earlier once-daily formulation had already been shelved in 2023 for the same reason. The exit narrows the oral GLP-1 race to Lilly's orforglipron and Novo Nordisk's oral semaglutide, and it is a cautionary safety case for the broader peptide-therapeutics field on hepatotoxicity surveillance.

A new investigative review in JAMA Ophthalmology reports nine patients taking semaglutide or tirzepatide who developed serious eye conditions, including nonarteritic anterior ischemic optic neuropathy (NAION), papillitis, and paracentral acute middle maculopathy. The findings build on a 2024 study linking semaglutide to NAION. Researchers stress the need for continued monitoring given widespread GLP-1 drug use.

This article explains what compounded semaglutide is and why it may pose safety risks. Compounded versions are not FDA-approved, so their quality, safety, and effectiveness are not verified. It distinguishes compounded semaglutide from the three FDA-approved products: Ozempic, Rybelsus, and Wegovy. The article serves as a consumer safety overview of the risks of using non-approved compounded formulations.

This is a consumer health guide detailing drug interactions and safety information for Ozempic (semaglutide). It covers the boxed warning for thyroid cancer risk, contraindications like medullary thyroid carcinoma and MEN2, and interactions with alcohol, insulin, and sulfonylureas. It also notes approved uses for type 2 diabetes, cardiovascular risk reduction, and chronic kidney disease.

Law firm Parker Waichman LLP is filing lawsuits alleging that patients taking GLP-1 receptor agonist medications Ozempic and Wegovy developed NAION, an irreversible eye condition causing vision loss. The firm has filed multiple suits on behalf of residents of Georgia, California, Ohio, and Massachusetts. It also welcomed strengthened NAION safety guidance from Health Canada and Australia's TGA, and a client shared her vision-loss story with FOX Boston 25 News.

Following a comprehensive review, the FDA found no increased risk of suicidal ideation or behavior with GLP-1 receptor agonist medications. The agency is requiring removal of SI/B warning language from the labels of Saxenda (liraglutide), Wegovy (semaglutide), and Zepbound (tirzepatide), which are approved for weight reduction. This updates a January 2024 safety communication and will align labeling across all FDA-approved GLP-1 RAs. Patients are advised to continue their medications and discuss concerns with their healthcare providers.

In this final notice, Takeda states that, in alignment with the US FDA, the NATPARA Special Use Program (SUP) closes on December 31, 2025, and no NATPARA shipments will be sent after that date. The letter follows the previously communicated global manufacturing discontinuation of NATPARA in December 2024. Prescribers are urged to develop alternate treatment plans for enrolled patients, including potential transition to the FDA-approved treatment for adult hypoparathyroidism (the letter links Yorvipath's prescribing information).

ASHP's live entry documents the ongoing vasopressin injection shortage and its supplier dynamics: Baxter has vasopressin premixed bags on shortage due to increased demand, Par's Vasostrict 1 mL vials and 100 mL premixes are back-ordered with no release estimate, and Eagle has discontinued vasopressin injection. American Regent, Amneal, Amphastar, Eugia, Fresenius Kabi, Long Grove (premixed vials) and Sagent have product available.

Ferring Pharmaceuticals US voluntarily recalled all marketed lots of DDAVP Nasal Spray, Desmopressin Acetate Nasal Spray and STIMATE Nasal Spray nationwide to the consumer level after routine stability testing found the products were superpotent. FDA's notice states the risk of excess desmopressin is abnormally low blood sodium (hyponatremia), which could eventually lead to seizure, coma, and death. One non-fatal adverse event potentially associated with the issue had been reported in the US.

ASHP's current shortage entry shows a contracting bivalirudin supply: Accord has temporarily discontinued bivalirudin 250 mg vials with no estimated release date, and Eugia (June 2025), Pfizer's 250 mg ADD-Vantage vials (early 2024), Sagent (early 2025) and Slate Run (October 2025) have all discontinued. Avenacy, Fresenius Kabi, Meitheal, Par (Endo), Sandoz and Viatris still have bivalirudin injection available. Argatroban is noted as an alternative direct thrombin agent for use during PCI.

The FDA issued an alert about dosing errors and overdoses linked to compounded injectable semaglutide products, with some adverse events requiring hospitalization. Errors stemmed from patients self-administering incorrect doses and providers miscalculating doses, often due to confusion over units and unfamiliarity with vial-based injections. The agency urges providers and compounders to counsel patients, supply appropriate syringes, and verify concentrations. Approved semaglutide products like Wegovy, Ozempic, and Rybelsus are not the focus of the alert.

The FDA warns patients and clinicians about unapproved and compounded versions of GLP-1 receptor agonist drugs like semaglutide and tirzepatide used for weight loss. Because compounded drugs do not undergo FDA review for safety, effectiveness, or quality, the agency says their use carries risks and should be limited to patients whose needs cannot be met by approved products. The FDA also lists red flags for consumers buying weight-loss medications via telehealth and offers recommendations for safe prescribing and purchasing.

The FDA has issued warning letters to 18 websites for illegally marketing unapproved and misbranded botulinum toxin products, commonly known as Botox. The agency warns that these products pose serious health risks, including the potential for botulism, a life-threatening condition that can cause muscle weakness and breathing difficulties. Officials emphasized that legitimate botulinum toxins require a prescription and carry a boxed warning due to their inherent risks, whereas unapproved versions may be counterfeit, contaminated, or improperly stored.

The FDA has issued a consumer warning advising against the use of over-the-counter HCG weight-loss products, stating the hormone is not approved for weight management. The agency highlights that these products, often sold as drops or sprays, are illegal and ineffective, attributing any weight loss to the accompanying severe 500-calorie diet rather than the hormone itself. Additionally, the FDA warns that the extreme calorie restriction recommended alongside these products poses significant health risks, including gallstones and heart issues.

The FDA's 2024-2025 updates to the Ozempic and Wegovy (semaglutide) prescribing information added warnings for ileus/intestinal blockage, pulmonary aspiration during anesthesia, and ongoing gastroparesis surveillance, reflecting accumulating postmarketing reports - including roughly 20 ileus reports with two deaths. A 2025 observational study found an increased gastroparesis incidence in semaglutide users versus a comparator weight-loss drug, and federal GLP-1 gastroparesis litigation (MDL 3094) has consolidated hundreds of claims. The label changes underscore that delayed gastric emptying - the drug's mechanism - has real downstream safety consequences that prescribers must manage.

On April 14, 2025, the FDA warned consumers and healthcare providers not to use counterfeit Ozempic (semaglutide) 1 mg injection that had entered the US drug supply chain after Novo Nordisk reported several hundred suspect units. The agency flagged risks of wrong active ingredient, incorrect dose, and contamination, and advised the supply chain to quarantine and verify the implicated lot. The alert sits atop a broader body of evidence - including pharmacovigilance analyses of suspected-counterfeit semaglutide where ~89% of reported adverse drug reactions were classified as serious (vomiting, nausea, hypoglycemia) - underscoring that the GLP-1 boom has spawned a parallel counterfeit and illicit-compounding safety problem.

As of May 31, 2026, the FDA reported 990+ adverse-event reports tied to compounded semaglutide and 730+ for other compounded GLP-1 products, citing risks from unapproved, non-sterile, or misbranded copycat products. The agency reiterated that compounded versions lack an FDA-approved-quality assurance.