Some medicines containing valsartan used for the treatment of high blood pressure and heart conditions are being recalled across Europe to be reviewed by the European Medicines Agency (EMA) to determine the extent of ingredient impurity.
Product recall
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. This impurity has the potential to cause cancer in humans.
It is believed that the presence of the NDMA impurity in the active ingredient is related to changes in the way the substance has been manufactured.
The review being performed by the EMA will look at the levels of NDMA in the affected valsartan medicines, any potential impact that may affect patients who have already been taking the medicines and what specific measures should be taken to lower or remove the impurity from any future batches produced by the Chinese company.
Additionally, precautionary measures will be taken by the EMA, which will review other valsartan medicines to ensure they have not also been affected.
A Class 1 Medicines Recall is now underway with all valsartan containing medicines made by Actavis Group and Dexcel Pharma being recalled at a European level as a result of the potential contamination.
In the UK, 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.
“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.
“We will communicate the outcome of our investigations and ensure that any other affected products are recalled. Our highest priority is to ensure that the medicines you take are safe.
“If you are concerned, please speak to your GP, pharmacist or other healthcare professional. We strongly encourage anyone taking valsartan medicines to report any suspected side effects, to us via our Yellow Card Scheme.”