Health Canada Warning re: Ezetrol (Ezetimibe)

Image by Steve Buissinne from Pixabay

Health Canada requires that new drugs be tested on animals. This is not only problematic because of the cruelty involved but also because, as many researchers recognize, animal models are a poor predictor for human outcomes – our physiology is different. On March 27, 2004, Health Canada sent out a warning regarding the drug Ezetrol (ezetimib). It’s based on “…a review of international safety data and the scientific literature [that] identified 42 post-marketing cases of DILI in patients taking Ezetrol, including a Canadian case of liver injury associated with ezetimibe monotherapy.” In other words, the warning, which is about the risks of “drug-induced liver injury and severe cutaneous adverse reactions” has come out after the drug was marketed to consumers. This is an example of animal models being poor predictors for human outcomes. In 2022, the U.S. eliminated its federal mandate for animal testing for new drugs and biosimilars with the FDA Modernization Act 2.0. We say it’s time Canada does the same. If you agree, please sign our petition by clicking here.

From Health Canada email sent March 27, 2024:

As a subscriber to Health Canada’s MedEffectTM e-Notice, you are being informed of the latest Health Product Risk Communication. 

Ezetrol (ezetimibe) and the Risks of Drug-Induced Liver Injury and Severe Cutaneous Adverse Reactions

Ezetrol (ezetimibe) may cause serious adverse reactions, including drug-induced liver injury (DILI) and severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilic and systemic symptoms (DRESS).

The Canadian Product Monograph for Ezetrol has been updated to include warnings about these serious adverse reactions. Health Canada will work with the manufacturers of generic versions of ezetimibe to update their respective CPMs.


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