- within Food, Drugs, Healthcare and Life Sciences topic(s)
- with Senior Company Executives, HR and Finance and Tax Executives
- in European Union
- in European Union
- with readers working within the Advertising & Public Relations, Business & Consumer Services and Insurance industries
Ozempic, a diabetes drug that has been the subject of multiple regulatory investigations due to its potential to expose users to serious health risks (including gastrointestinal issues and vision loss), has been approved to treat a new type of chronic health condition: kidney decline.
Ozempic is a drug prescribed for glycemic control in type 2 diabetics
Ozempic (active ingredient: semaglutide) was initially approved by Health Canada in 2018 for the treatment of adult patients with type 2 diabetes to improve glycemic control. Since then, Ozempic has become exceedingly popular, with the National Prescription Drug Utilization Information System reporting that it was the top-selling medicine reimbursed by private drug plans in Canada in 2023.1
For the first several years that the drug was available in Canada, Canadian Product Monograph for Ozempic contained no warnings or precautions regarding certain potential serious side effects, including gastroparesis, a condition of "delayed gastric emptying" where food sits undigested in the gastrointestinal system and can form obstructions, and non-arteritic anterior ischemic optic neuropathy (NAION), a condition where loss of vision is caused by damage to the optic nerve.
Global medicines regulator finds links between Ozempic and gastroparesis, NAION
In recent years, major global pharmaceutical regulators, including the United States' Food and Drug Agency (FDA) and the European Union's European Medicines Agency (EMA), have investigated alleged links between Ozempic and gastroparesis and Ozempic and NAION.
In 2022, the FDA reported it was evaluating the need for regulatory action regarding Ozempic due to a potential signal of a serious risk of intestinal obstruction. And, in 2023, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) published a report concluding that a causal relationship between Ozempic and delayed gastric emptying was a "reasonable possibility."
Following the fourth quarter of 2024, the FDA reported it was now evaluating the need for regulatory action regarding Ozempic due to a potential signal of a serious risk of NAION. And, at a June 2025 meeting of the PRAC, the agency announced that there was now "sufficient evidence to establish a causal relationship between semaglutide and NAOIN".
Despite the findings, the Canadian Product Monograph still lacks information about these risks.
As of August 2025, the "Warnings and Precautions" section contains no statements about NAION whatsoever, and the statements provided in that section regarding gastroparesis – which were not added until March 2024 – are that "Use of GLP-1 receptor agonists may be associated with severe gastrointestinal disease (ileus)" and "Events of delayed gastric emptying, dysgeusia and ileus have been reported in the post marketing database with an unknown frequency."
Despite the risks, Ozempic has been approved for a new use that may impact thousands
Despite the causal relationship to these serious side effects, Ozempic has received approval for a new indication for use in Canada.
In August 2025, Ozempic was approved to reduce the risks of end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). In the press release accompanying the news, Ozempic's manufacturer states that "CKD is a major health problem affecting approximately 4 million Canadians, "and a doctor is quoted as saying that Ozempic offers "a better chance of avoiding kidney failure or cardiovascular complications."
As a result of the new approved use, any of the 4 million Canadians suffering from CKD who are subsequently prescribed Ozempic may be exposed to risks of gastroparesis and NAION. And those patients and their doctors may not have sufficient warnings of those risks.
Ozempic / GLP-1 Receptor Agonist Claims
Siskinds LLP is seeking to recover compensation for Canadians who suffered injuries resulting from their use of prescription Ozempic or other GLP-1 receptor agonist drugs, like Rybelsus, Wegovy, Saxenda, Victoza, Trulicity, and Mounjaro.
Footnote
1 Patented medicine prices review – Canada
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
