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UK and Irish regulators recall valsartan drugs over impurity concerns

July 12, 2018 By pharmaceutical-technology
Tag: Drugs , UK , Irish

UK and Irish regulatory authorities have recalled all batches of valsartan containing drugs manufactured by Dexcel Pharma and Accord Healthcare, previously known as Actavis Group.

Therapeutics containing valsartan as the active ingredient are commonly used for the treatment of high blood pressure and heart disorders.

The UK’s Medicines and Healthcare products Regulatory Agency’s (MHRA) and Irish Health Products Regulatory Authority (HPRA) said that the recall is a precautionary measure.

The move comes after the detection of an impurity, N-nitrosodimethylamine, in a valsartan active substance produced at a facility in China, which supplied the substance to Dexcel and Accord.

It was further noted that the impurity may possess carcinogenic potential and is due to a change made in the manufacturing process of valsartan.

Currently, all the European Union (EU) regulators are jointly conducting an investigation to determine the extent of the situation and any possible impact on patients.

“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.”

MHRA Inspection, Enforcement and Standards division director Dr Sam Atkinson said: “We continue to undertake an urgent review of all these products that may pose a low risk to public health.

“We will communicate the outcome of our investigations and ensure that any other affected products are recalled. Our highest priority is to ensure that the medicines you take are safe.

The regulatory authorities have advised patients, who are currently taking affected valsartan drugs, to not stop using the medication and consult their doctor.

Alternative medicines containing valsartan and unaffected by this issue remain available in the UK and Ireland market.

The European Medicines Agency is working with regional regulators to investigate the extent of the issue and its possible impact for patients.

HPRA chief executive Dr Lorraine Noland said: “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.

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