MHRA recalls blood pressure drug due to impurity

The Medicines and Healthcare products Regulatory Agency (MRHA) has announced a pharmacy level recall of a blood pressure drug made by Mylan and Teva.

The recall, issued to Mylan and Teva’s blood pressure drug valsartan, has been made as a precautionary measure according to the MHRA and is for all affected batches of valsartan containing medicines by the manufacturers.

Earlier this year, a previous recall of valsartan was issued due to the discovery of an impurity identified during the manufacturing process at a facility in China. An investigation into that impurity has now led to the discovery of N-nitrosodiethylamine (NDEA) within the valsartan drug substance.

The MHRA and other EU regulators are now investigating other valsartan products which share a similar chemical structure to valsartan.

The organisation has stressed that there is currently no evidence of patient harm caused by the impurity and that the recall is being undertaken as a precautionary measure.

People are also urged to consult with their doctor or pharmacist before stopping any treatments, due to risk associated with suddenly stopping high blood pressure medication.

Dr Sam Atkinson MHRA’s director of the Inspection, Enforcement and Standards Division said: “Our highest priority is making sure the medicines you take are safe. We are undertaking a pharmacy level recall of all affected batches of Valsartan containing medicines made by Mylan and Teva. This is a precautionary measure to prevent any further exposure to the impurity in the affected medicines whilst the investigation continues and further updates will be provided.”

“We strongly encourage anyone taking valsartan medicines to report any suspected side effects, to us via our Yellow Card Scheme,” Atkinson added.