Pharmacies are being advised to recall all batches of valsartan-containing medicines made by Dexcel Pharma Ltd and Accord Healthcare (previously known as Actavis Group) following an urgent investigation into medicines containing valsartan, which are used to treat high blood pressure and heart conditions.
The UK product recall was issued by the Medicines and Healthcare products Regulatory Agency (MHRA) on 5 July 2018, and a recall is underway across Europe following recent information that an impurity has been identified as part of the manufacturing process in a valsartan active substance manufactured in China.
The impurity (N-nitrosodimethylamine), which could be carcinogenic, is a result of a change in the manufacturing process. This active substance is used in a number of medicines marketed in Europe.
The European Medicines Agency and other EU regulators are working together to investigate the extent of the issue and any possible impact for patients.
Sam Atkinson, MHRA’s director of the Inspection, Enforcement and Standards Division, 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.”
The MHRA said that, in 2017, there was a total of 424,625 prescriptions of all strengths for valsartan for NHS England (not including combination products or hospital prescriptions). The figure also includes valsartan products not affected by the recall.
Alternative valsartan-containing products that are unaffected by this issue are available in the UK.