Pharmacies advised to recall valsartan products

The European Medicines Agency is reviewing medicines containing valsartan supplied by a facility in China after a potentially cancer-causing impurity was detected.

Valsartan was originally developed by Novartis and the Swiss company marketed it as Diovan, but it is now off patent and is used in a number of generic medicines. It is also sometimes prescribed after a heart attack.

Dr Sam Atkinson, director of the inspection, enforcement and standards division at the MHRA, said: "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".

A review underway by the European Medicines Agency (EMA) and national agencies focused on medicines containing valsartan manufactured by China's Zhejiang Huahai Pharmaceuticals, the medicines agency said.

The ministry called on medicine distributors and pharmacies to stop selling all valsartan-based medicines, including VALSARTAN WIN 80 mg and 160 mg, CO-VALSARTAN WIN 80 mg/12.5mg and 16 mg/25 mg and ATENSIL 40 mg, 80 mg and 160 mg.

The impurity N-nitrosodimethylamine (NDMA) that has been found is classified as a probable carcinogen.

"The European Medicines Agency and other EU regulators are working together to investigate the extent of the issue and any possible impact for patients". At this time, a precautionary recall of implicated products is the most appropriate action to protect patient health. "We are engaging with healthcare professionals to manage this situation".

The HPRA will provide further updates on this matter as more information becomes available.

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