Global recall of heart drug due to potential carcinogen contamination

Health Canada

Health Canada

The decision was given following the previous announcements of the European Medicines Agency (EMA), Health Canada and other medical management authorities on the withdrawal of Valsartan-containing medicines produced by the mentioned company.

Health Canada is warning that several drugs containing an ingredient used to treat high blood pressure and prevent heart attacks and strokes are being recalled because they were found to contain a cancer-causing impurity.

There is no acute health threat to patients using the affected medication containing valsartan.

This recall is a precautionary measure taken by the ministry following a 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. 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. They are also used by patients who have had heart failure or a recent heart attack.

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"People taking valsartan medication affected by this recall are advised to not stop taking their medication, but to speak to their doctor or healthcare professional who can advise on alternative treatment", asserted Dr Sam Atkinson, MHRA's director of the Inspection, Enforcement and Standards Division.

"We continue to undertake an urgent review of all these products that may pose a low risk to public health".

Five companies sell drugs containing valsartan in Canada, including Sanis, Sandoz and Teva Pharmaceutical Industries.

"An investigation into other potentially impacted products is now being undertaken and further updates will be provided as the investigation progresses", the MHRA said.

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