Precautionary recall of some Valsartan blood pressure and heart medicines

Precautionary recall of some Valsartan blood pressure and heart medicines

Precautionary recall of some Valsartan blood pressure and heart medicines

The impurity is due to a change in the manufacturing process at one facility in China that supplied the manufacturers with the active ingredient - used to treat high blood pressure and heart conditions - the watchdog said.

Bulgaria's medicines agency said on July 6 that it was suspending the sale of 62 high blood pressure and heart medications, as part of a Europe-wide recall, after a potentially harmful impurity was found in the active substance manufactured in China.

The alert affects several countries since N-nitrosodimethylamine (NDMA) was detected in the active substance "valsartan", added the statement. It is also sometimes prescribed after a heart attack.

"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", said Dr Sam Atkinson, MHRA's Director of the Inspection, Enforcement and Standards Division.

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National authorities across the European Union are now recalling medicines containing valsartan supplied by Zhejiang Huahai while a review investigating levels of NDMA is undertaken.

A spokesperson for Celesio - parent company of Lloydspharmacy and wholesaler AAH - has confirmed its pharmacies have removed the affected products, in line with MHRA advice. At present there is no evidence that this impurity has caused any harm to patients; however, this recall action is being undertaken as a precautionary measure to prevent any further exposure to the impurity in the affected medicines whilst the investigation is ongoing. "We are engaging with healthcare professionals to manage this situation".

· Patients should not stop taking their treatment abruptly.

European regulators said they were working together to investigate the extent of the issue.

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