Ozempic, the popular drug approved in Canada to treat diabetes, has been linked to serious harms to users.
Studies have shown a link between the use of semaglutide – the active ingredient in Ozempic – and an increased risk of severe gallbladder-related harms, including gallstones, and gastrointestinal issues, including “stomach paralysis” and intestinal blockages. Despite these reports, there are no specific warnings for severe stomach, intestinal, or gallbladder harms in the Canadian warning information for the drug.
Siskinds is now pursuing claims on behalf of Canadians who suffered serious gastrointestinal or gallbladder harms after using semaglutide drugs. On October 6, 2023, Siskinds filed a proposed Canadian class action on behalf of patients who used Ozempic, Rybelsus, and Wegovy, alleging that semaglutide drugs expose patients to serious risks, which were not sufficiently warned of.
Ozempic, semaglutide drugs are medications widely prescribed for diabetes, weight loss
Ozempic is a pharmaceutical approved by Health Canada to treat type 2 diabetes by way of injection. A pill form of semaglutide, Rybelsus, is also available in Canada as a diabetes treatment.
The makers of Ozempic and Rybelsus, the Novo Nordisk group of companies, also manufacture a form of semaglutide, called Wegovy, which is approved by Health Canada for chronic weight management but not yet available in Canadian pharmacies. However, Wegovy is available in the US.
Semaglutide drugs are now among the most widely prescribed medications in Canada. In 2022 alone, 3.5 million prescriptions of Ozempic were reportedly dispensed by Canadian drugstores.[1]
Studies have linked Ozempic use to gallbladder and gastrointestinal issues
For years, scientific studies have shown connections between the “GLP-1 agonists” class of medications (the class of pharmaceuticals to which Ozempic belongs) and an increased risk of gallbladder-related diseases and gastrointestinal issues. Notable findings include:
- A 2016 study of over 70,000 patients which found GLP-1 agonists to be associated with a significantly increased risk of bile duct and gallbladder disease in patients with type 2 diabetes when compared to use of other oral antidiabetic drugs;[2]
- A 2021 meta-analysis funded by Novo Nordisk and comprising almost 12,000 semaglutide users, which noted a 28% increased risk of gallstones with the treatment;[3]
- A two-year study published in 2022 examining semaglutide treatment in overweight or obese users, which found over 82% of semaglutide users experienced mild to moderate gastrointestinal adverse events compared with only just over half of non-users;[4]
- A 2023 publication that used a random sample of 16 million patients to examine gastrointestinal events linked to GLP-1 agonists, which concluded that the drugs are associated with a significantly increased risk of bowel obstruction and stomach paralysis.[5]
Ozempic label lacks sufficient warnings of stomach, gallbladder harms
Despite the scientific evidence of the associated risks of gastrointestinal and gallbladder-related illnesses, the Canadian Product Monographs for Ozempic lack sufficient warnings of these potential side effects.
Product Monographs are documents designed to provide medical professionals and patients with all relevant information on the uses, dosages and risks associated with pharmaceutical drugs.
In the current Canadian Product Monographs for all semaglutide products, the “Serious Warnings and Precautions” sections for doctors and consumers (aka the “Black Box Warnings”) – the most stringent type of warning for medications – contain no reference to gallbladder issues or gastrointestinal issues whatsoever. The general “Warnings and Precautions” sections in the current Canadian semaglutide Product Monographs also make no mention of gastroparesis, stomach paralysis, delayed stomach or gastric emptying, or stomach or intestinal blockages.
Siskinds is pursuing justice for Ozempic users who have been harmed
Siskinds is seeking to recover compensation for Canadians suffering severe gastrointestinal or gallbladder issues resulting from their use of prescription Ozempic, Rybelsus, or Wegovy. If you or someone you know has used Ozempic, Rybelsus, or Wegovy and has suffered serious stomach, gallbladder, or other gastrointestinal harms, Siskinds may be able to help.
Contact us for more information or to receive a free consultation. Visit siskinds.com/ozempic and complete the form at the bottom of the page or call 1-800-461-6166. Quebec residents should contact Siskinds Desmeules by phone at 418-694-2009 or by email at [email protected].
[1] https://nationalpost.com/health/how-ozempic-works
[2] Faillie, Jean-Luc et al. “Association of Bile Duct and Gallbladder Diseases With the Use of Incretin-Based Drugs in Patients With Type 2 Diabetes Mellitus.” JAMA internal medicine vol. 176, 10 (2016): 1474-1481. doi:10.1001/jamainternmed.2016.1531
[3] See Smits MM, Van Raalte DH. “Safety of Semaglutide.” Front Endocrinol (Lausanne). 2021 Jul 7; 12:645563. doi: 10.3389/fendo.2021.645563;
[4] Garvey, W.T., Batterham, R.L., Bhatta, M. et al. “Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial.” Nat Med 28, 2083–2091 (2022). https://doi.org/10.1038/s41591-022-02026-4;
[5] Sodhi M, Rezaeianzadeh R, Kezouh A, Etminan M. “Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss.” JAMA. Published online October 05, 2023. doi:10.1001/jama.2023.19574