Recall of Valsartan containing drugs

Health Canada

A sign is displayed in front of Health Canada headquarters in Ottawa on Jan. 3 2014

Pharmacies in 22 countries including Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta have been warned and asked to recall products containing Valsartan as a precaution. This recall is a precautionary measure taken by the Ministry following the report issued by the European Medicines Agency indicating the detection of a contamination of the active ingredient with N-nitrosodimethylamine (NDMA), a chemical that might lead to cancer.

Issue: Several drugs containing the ingredient valsartan are being recalled by their manufacturers.

Health Canada says patients taking the drug should check with their pharmacists to learn if their medicine is being recalled.

NDMA is a potential carcinogen that could cause cancer with long-term exposure. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured, the EMA said. Doctors advised that people should not stop taking medicine without first consulting a professional specialist.

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"Patients should not stop taking their medicine if it contains valsartan unless they've been specifically instructed to do so by their prescriber or pharmacist", Nakhla said. As a precaution, the review will also consider whether other valsartan medicines may be affected.

If you have any questions about your treatment, speak to your pharmacist who can tell you if your medicine is being recalled.

EMA and United Kingdom regulators are working together to investigate the extent of the issues and any possible impact for patients.

Drugs containing valsartan are used to treat patients with high blood pressure to help prevent heart attacks and stroke.

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