Drugs recalled over impurity classed as ‘probable carcinogen’

A number of drugs used to treat blood pressure and heart conditions are being recalled as a precautionary measure after an impurity believed to cause cancer was found in them.

The recall is understood to affect about 50,000 patients in Ireland.

The Health Products Regulatory Authority (HPRA) said on Thursday it was a "precautionary recall of a number of specific medicines containing the active ingredient valsartan.

"A recall is under way across Europe following recent and emerging information that an impurity has been identified as part of the manufacturing process in a valsartan-active substance manufactured at one facility in China. This active substance is used in a number of medicines marketed in Europe," the HPRA said.

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Valsartan is an important prescription medicine used to treat high blood pressure and heart failure. It is also sometimes prescribed after a heart attack.

The regulator advised patients not to stop taking the medicines but to go to their pharmacist or doctor at an early opportunity to discuss their treatment.

“Not all valsartan medicines are affected by the recall. There are alternative valsartan-containing medicines and other treatments available to patients,” it said.

The impurity N-nitrosodimethylamine (NDMA) that has been found is classified as a probable carcinogen.

“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,” the regulator added.

‘Extent’

HPRA chief executive Dr Lorraine Nolan said this was "an emerging situation being managed in real time by the HPRA working with the European network of medicine regulators in order to determine the extent of the issue".

“Laboratory testing and risk assessments will provide more information as part of this co-ordinated European approach to establish the possible impact on patients who have been taking these medicines and to ascertain if other products may be impacted. At this time, a precautionary recall of implicated products is the most appropriate action to protect patient health. We are engaging with healthcare professionals to manage this situation,” Dr Nolan added.

The HPRA said that in addition to working closely with the European regulatory network on the investigation, it was informing all stakeholders including the Department of Health, the Pharmaceutical Society of Ireland, the Irish College of General Practitioners and others of the regulatory action. It said it would provide further updates as more information became available.

The products include some manufactured by Clonmel Healthcare Ltd, by Rowex Ltd and by Actavis Group PTC. They include some products with names including Vatan, Valtan, Co-Vatan and Valsartan Actavis.

A list of the affected products is available online at hpra.ie/valsartan