ARTICLE
23 October 2024

New Warnings For Gastroparesis, Severe Stomach Problems Added To Popular GLP-1 Drugs

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Siskinds LLP

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Since 1937, Siskinds has been that firm of specialists serving individuals, families and businesses in southwestern Ontario and Canada from our offices in London, Sarnia and Quebec City. We’ve grown as the world around us has evolved. Today, we are a team of over 230 lawyers and support staff covering personal, business, personal injury and class action law and over 25 specialized practice areas.
The Canadian product information for in-demand type 2 diabetes drugs Mounjaro and Trulicity has recently been updated with new warning language describing certain serious gastrointestinal risks...
Canada Food, Drugs, Healthcare, Life Sciences

The Canadian product information for in-demand type 2 diabetes drugs Mounjaro and Trulicity has recently been updated with new warning language describing certain serious gastrointestinal risks, including gastroparesis (aka stomach paralysis).

The updated warnings for Mounjaro and Trulicity come in the wake of new warnings for gastrointestinal issues being added to market-leading diabetes drug Ozempic earlier this year.

GLP-1 drugs (Ozempic, Mounjaro, Trulicity) are popular treatments for diabetes type 2, weight loss

Trulicity, Mounjaro, and Ozempic are all part of a class of medications called glucagon-like peptide-1 (GLP-1) and dual GLP-1/GIP (glucose-dependent insulintropic polypeptide) receptor agonists, which are used to type 2 diabetes and, with respect to certain drugs, for chronic weight management. GLP-1 drugs work by mimicking the GLP-1 hormone, which is a hormone released in the gastrointestinal tract in response to eating that prompts the body to produce more insulin and also interacts with parts of the brain that reduce appetite and signal a feeling of fullness.1

GLP-1 drugs have become increasingly popular in recent years. High demand for certain GLP-1 and dual GLP-1/GIP drugs, including Ozempic (Semaglutide), Trulicity (dulaglutide), and Mounjaro (tirzepatide), has resulted in Canadian supply shortages for all three drugs in 2024.2

Scientific studies have shown connections between the use of GLP-1 drugs and an increased risk of gastrointestinal issues,3 including gastroparesis.4 Gastroparesis, also known as stomach paralysis or delayed gastric emptying, is a condition in which undigested food stays in the stomach for prolonged periods of time and can cause severe nausea, vomiting and severe abdominal pain.

New warnings for delayed gastric emptying added for Trulicity, Mounjaro, Ozempic in 2024

Product Monographs are Health Canada-approved documents that provide doctors and patients with information on the uses, dosages and risks associated with medications. Despite the scientific studies concerning GLP-1 drugs, prior to 2024 nothing in the "Warnings and Precautions" sections for healthcare professionals in the product monographs for Ozempic, Mounjaro or Trulicity acknowledged gastroparesis or delayed stomach emptying as a side effect of any of the drugs.

In March 2024, the Warnings and Precautions section for doctors in the monograph for Ozempic was updated to state that the "Use of GLP-1 receptor agonists may be associated with severe gastrointestinal disease" and that "Events of delayed gastric emptying, dysgeusia and ileus have been reported". The Patient Medical Information section of the monograph was also updated to add "delay in emptying of the stomach" as a known possible side effect.

Then in July 2024, the monographs for Mounjaro and Trulicity were also updated with new warnings.

The Warnings and Precautions sections for healthcare professionals for Mounjaro and Trulicity were updated to notify doctors that "Events related to impaired gastric emptying, including severe gastroparesis, have been reported" and to "Monitor and consider dose modification or discontinuation in patients who develop severe gastrointestinal symptoms while on treatment." The Patient Medical Information for both drugs was also updated to add language to alert users that "Stomach problems, sometimes severe, have been reported" in people who use the drugs and that patients should "Tell your healthcare provider if you have stomach problems that are severe or will not go away."

Siskinds is assisting Canadians who have been harmed by GLP-1 drugs

Siskinds is seeking to recover compensation for Canadians suffering severe stomach issues and other serious health issues resulting from their use of prescription GLP-1 drugs, such as Ozempic, Rybelsus, Wegovy, Trulicity, and Mounjaro. Siskinds LLP has filed a class action alleging that the makers of Ozempic drugs failed to adequately warn patients of serious gastrointestinal harms.

Footnotes

1. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss

2. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-shortages/information-consumers/supply-notices/ozempic.html

3. 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;

4. 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

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.

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