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Original Advisory (May 30, 2021): Multiple lots of irbesartan, losartan and valsartan drugs recalled due to azido impurity
Health Canada is informing Canadians that several companies are recalling multiple lots of irbesartan, losartan and valsartan drug products after tests found an azido impurity above the acceptable limit (see list of affected products below).
Irbesartan, losartan and valsartan are all prescription angiotensin receptor blocker (ARB) drugs, which are also known as "sartans." Sartans are a class of drugs used to treat patients with high blood pressure to help prevent heart attacks and stroke. They are also used in patients with heart failure or those who have had a recent heart attack.
The azido impurity, 5-(4'-(azidomethyl)-[1,1'-biphenyl]-2yl)-1H-tetrazole, is considered a mutagen. A mutagen is a chemical substance that can cause a change in the DNA of a cell. These mutations may increase the risk of cancer but the specific risk for this azido impurity to cause cancer in humans is unknown.
There are established international guidelines that recommend that mutagenic impurities be kept at or below a specific level because exposure to a mutagen over the long term at a level above what is considered to be safe, has the potential to increase the risk of cancer. A person taking a drug daily for 70 years that contains this azido impurity at or below the acceptable level is not expected to have an increased risk of cancer.
Not all lots of irbesartan, losartan and valsartan from these companies are affected by this issue; however, it is possible that the recalls may affect the supply of some products. Patients should speak with their doctor or pharmacist to discuss alternatives should their regular prescribed drug not be available.
The Department expects manufacturers to take any necessary actions to reduce or eliminate the azido impurity. Impacted companies have been directed to implement control measures to ensure that the level of the impurity in their products are at or below the acceptable level. Health Canada is monitoring the effectiveness of the recalls. Should additional recalls be deemed necessary, Health Canada will inform Canadians.