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Drugs regulator asks pharmacies to return more valsartan meds

Move is precautionary and follows earlier pharmacy level recall in July

Caroline White

Monday, 03 December 2018

The drugs regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), is asking pharmacies to return all affected batches of valsartan containing medicines, used to treat high blood pressure and various heart conditions, manufactured by Mylan and Teva, as a precautionary measure.

The move follows an earlier pharmacy level recall in July, when the MHRA recalled affected batches of valsartan containing medicines from Dexcel and Actavis (now Accord).

That recall occurred across Europe, as a result of information that an impurity, N-nitrosodimethylamine (NDMA), which may be carcinogenic, had been identified as part of the manufacturing process in a valsartan active substance made at one facility based in China.

During the course of the investigation into NDMA, another impurity, N-nitrosodiethylamine (NDEA), was discovered in a valsartan drug substance. MHRA, together with other EU regulators, is continuing to investigate other sartan products which share a similar chemical structure to valsartan.

At present, there is no evidence that this impurity has caused any harm to patients, emphasises the agency, explaining that this further recall is being undertaken as a precautionary measure to prevent further exposure to this impurity in the affected medicines while the investigation is ongoing.

Due to the risk associated with suddenly stopping high blood pressure medication, people are advised not to stop any treatments without first speaking to their doctor or pharmacist.

The MHRA says that it is working closely with other EU member states, the European Medicines Agency (EMA), and the European Directorate for the Quality of Medicines (EDQM) to make sure the investigation is thorough and to find out what further actions may be necessary.

Dr Sam Atkinson, MHRA’s director of the inspection, enforcement and standards division said the agency’s highest priority was medicines safety, emphasising that the latest recall was “a precautionary measure to prevent any further exposure to the impurity in the affected medicines whilst the investigation continues.”

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

Further updates would be provided, she said.

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