Published: Fri, July 13, 2018
Medicine | By Earnest Bishop

Global recall of heart drug due to potential carcinogen contamination

Global recall of heart drug due to potential carcinogen contamination

The recall and review were sparked after Zhejiang Huahai Pharmaceuticals - the company that supplies the active ingredient for some valsartan medicines - detected an impurity, N-nitrosodimethylamine (NDMA), in their product.

Health Canada is urging users of medication containing valsartan, which is used to treat high blood pressure, to consult with their physician and pharmacist to determine what to do in the wake of a recall of products containing valsartan issued by five companies.

Explaining how the NDMA may have been introduced into the active substance, the EMA suggested it was likely to have been introduced due to changes in the way the ingredient was manufactured.

The recall affects several drugs containing the ingredient valsartan, Health Canada announced Tuesday.

As a precautionary measure, the valsartan-containing medications are recalled on a pharmacy level.

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The agency listed 28 impacted products containing valsartan being recalled by their manufacturers.

EMA is now evaluating potential impact on patients of the exposure to NDMA in valsartan medicines. Patients that have had a recent heart attack or heart failure also use these drugs.

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) is working with pharmacies to recall the affected medicines but have also stated the importance of patients continuing their treatment but to seek advice from a healthcare professional immediately.

"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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