A series of drugs used to treat patients with high blood pressure are being recalled due to a potential carcinogen impurity.
Health Canada says Losartan, an active pharmaceutical ingredient in the products made by Hetero Labs Ltd. in India, has a nitrosamine impurity.
Long-term exposure to the impurity could increase the potential risk of cancer.
Pharmaceutical company Teva Canada is voluntarily recalling two lots of combination Losartan/hydrochlorothiazide tablets after testing identified levels of nitrosamine above what is considered reasonably safe if the drug were taken over a lifetime.
Apotex Inc., Pharmascience Inc. and Pro Doc Limitée are also voluntarily recalling products as a precaution.
The following products are affected:
Health Canada says there are alternative products currently available on the Canadian market. Patients with questions or concerns about any drug they are taking, including on what to do if that drug is not readily available, should speak to their healthcare professional.
Officials say there is no immediate risk to patients since the potential risk of cancer is with long-term exposure to the impurities. Patients should not stop taking their medication unless advised to do so by their healthcare provider.
Losartan is an angiotensin receptor blocker drug, also known as a “sartan” — a class of drugs used to treat patients with high blood pressure to help prevent heart attacks and stroke.
Health Canada says they continue to work with partners like the U.S. Food and Drug Administration and the European Medicines Agency to assess the issue of nitrosamine impurities in certain sartan drugs.
In December, Health Canada requested all companies that market sartans in Canada to test products already on the market.
After a review of information from a U.S. FDA inspection, Health Canada has found Hetero Labs Ltd. Unit 1 to be non-compliant with requirements for good manufacturing practices .
They now have a non-compliant rating, meaning Canadian companies can no longer import drugs that contain active pharmaceutical ingredient’s from this site unless they are medically necessary.
More details on the recall can be found here