Multiple lots of drugs containing the active ingredient Losartan are being voluntarily recalled by the manufacturers, according to Health Canada, because they might contain a potential human carcinogen.
Teva Canada is voluntarily recalling two lots of combination Losartan/hydrochlorothiazide (HCTZ) tablets after testing found that they contained levels of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) that were higher than would be safe if the drug was taken over a lifetime, according to Health Canada.
NMBA is considered a potential human carcinogen, meaning that long-term exposure could potentially increase the risk of cancer.
Apotex, Pharmascience and Pro Doc Limitée are also voluntarily recalling many of their Losartan-containing products as a precaution, according to Health Canada.
All these drugs contain Losartan manufactured at a lab in India. After reviewing information from the U.S. Food and Drug Administration, Health Canada determined that it does not have good manufacturing processes and Canadian manufacturers can no longer import drugs with active ingredients from this site.
Losartan drugs are used to treat people with high blood pressure to help prevent heart attacks and stroke. They’re also used to treat patients who have recently had a heart attack or heart failure.
There were multiple recalls of similar drugs, containing valsartan as an active ingredient, since last summer, also due to problems with nitrosamine impurities.
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Health Canada says that because the risk of these drugs is long-term, there is no need for people to immediately stop taking them and should not do so unless advised by their health-care provider. Patients should take their questions and concerns to their health-care provider.
There are alternative drugs on the market, according to Health Canada.
The recalled drugs include specific lots of Apo-Losartan, Apo-Losartan/HCTZ, Losartan, PMS-Losartan, and Teva-Losartan/HCTZ. A full list of recalled drugs and lot numbers can be found on the Health Canada website.
Health Canada also suggests that people with questions about the recall to contact the manufacturer:
- Apotex Inc. via Stericyle Inc. by calling toll-free at 1-877-492-4795
- Pharmascience Inc. by calling toll-free at 1-800-340-9735
- Pro Doc Limitée by calling toll-free at 1-800-361-8559, or by email at medinfo@prodoc.qc.ca
- Teva Canada by calling toll-free at 1-800-268-4129, or by email at customer.service@tevacanada.com
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