Health Canada releases test results of certain sartan drugs

Issue

Health Canada has released the results of its testing of sartan drugs in Canada. Health Canada tested samples of certain sartan drugs (valsartan, candesartan, irbesartan, losartan, and olmesartan), which represent numerous products, as part of its ongoing collaborative work to address impurities found in some sartan drugs in Canada and internationally. Sartans, also known as angiotensin II receptor blockers (ARBs), are a class of drugs used as a treatment for patients with high blood pressure to help prevent heart attacks and stroke. They are also used in patients who have had heart failure or a recent heart attack. Several valsartan products have been recalled in Canada since this summer, after the impurities N‑nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA) were found in the active pharmaceutical ingredient. Both NDEA and NDMA are classified as probable human carcinogens, which means that long-term exposure could increase the risk of cancer. Health Canada has previously communicated cancer risk estimates for NDMA based on the levels detected in certain recalled valsartan products. Health Canada tested 48 samples representing 43 different products and did not identify any new safety concerns. Of the 48 samples, six valsartan samples representing four products were found to contain levels of impurities that were, on average, higher than what is considered to be reasonably safe. All four of the products have already been recalled from the Canadian market.

What you should do

• As with previous communications regarding NDEA and NDMA, Health Canada is advising that there is no immediate risk to patients taking these medications, since the risk of cancer is with long-term exposure to the impurities that exceed safe levels. Patients should not stop taking their medication unless on the advice of their healthcare provider.