Potential ‘human carcinogen’ leads to recall of Losartan-containing drugs

Multiple high blood pressure medications containing Losartan are being voluntarily recalled due to a “potentially human carcinogen,” Health Canada says.

Teva Canada, Apotex Inc., Pharmascience Inc,m and Pro Doc Limitée are recalling lots of Losartan-containing drugs because of the potential for a nitrosamine impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – a potential human carcinogen meaning that long-term exposure could increase the potential risk of cancer.

As with previous recalls involving nitrosamine impurities, Health Canada is advising that there is no immediate risk to patients taking these medications 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,” Health Canada says.

Teva Canada is voluntarily recalling two lots of combination Losartan/hydrochlorothiazide (HCTZ) tablets after testing of one lot identified levels of NMBA above what is considered reasonably safe if the drug were taken over a lifetime. Apotex Inc., Pharmascience Inc., and Pro Doc Limitée are voluntarily recalling multiple lots of Losartan-containing products as a precaution.

The Losartan active pharmaceutical ingredient (API) in all of the recalled products is manufactured by Hetero Labs Ltd. Unit 1, in India. These recalls represent all lots of drugs distributed in Canada that contain Losartan API manufactured at Hetero Labs Ltd. Unit 1.

Losartan is an angiotensin receptor blocker (ARB) drug, also known as a “sartan.” 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 who have had heart failure or a recent heart attack. There have been multiple recalls of products containing another sartan, valsartan, in Canada and internationally since July 2018 because of nitrosamine impurities (see links below for more information).

There are alternative products currently available on the Canadian market.

Health Canada continues to monitor the supply situation. Health Canada encourages Canadians to visit drugshortagescanada.ca for information on drug shortages and discontinuances. 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.

For a list of affected products, visit healthycanadians.gc.ca.

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