Medications to treat heart failure recalled

Medications to treat heart failure recalled

Widely taken blood pressure drug valsartan recalled | News

In the United Kingdom, the MHRA said it is advising pharmacies to recall all batches of valsartan containing medicines made by Dexcel Pharma and Accord Healthcare (previously known as Actavis Group) as a precaution.

The medicines regulator issued its recall of valsartan-containing medicines made by Dexcel Pharma Ltd and Accord Healthcare following a Europe-wide recall of the medicine which is used to treat high blood pressure and heart conditions.

The European Medicines Agency (EMA) is reviewing medicines containing the active ingredient Valsartan supplied by a facility in China, after a potentially carcinogenic impurity was detected in it.

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

Dr Sam Atkinson, MHRA director of the inspection, enforcement and standards division, said: "We will communicate the outcome of our investigations and ensure that the medicines [taken by patients] are safe".

The MHRA said that, in 2017, there was a total of 424,625 prescriptions of all strengths for valsartan for NHS England (not including combination products or hospital prescriptions). The figure also includes valsartan products not affected by the recall. At this time, a precautionary recall of implicated products is the most appropriate action to protect patient health.

The agency's Committee for Medicinal Products for Human Use (CHMP), is reviewing the possible impact of NDMA on patients and what steps can be taken to eliminate the impurity from future batches of product.

The HPRA will provide further updates on this matter as more information becomes available.

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