Published: Sun, July 08, 2018
Medicine | By Tracy Klein

Common heart drug recalled in 22 countries for possible cancer link

Common heart drug recalled in 22 countries for possible cancer link

Britain's Medicines and Healthcare products Regulatory Agency said the appearance of the impurity - N-nitrosodimethylamine - came after a change in the process for making valsartan at one facility.

The Medicines and Healthcare products Regulatory Agency (MHRA) has urged pharmacies in the United Kingdom to recall all batches of valsartan medicines as a precaution amid fears that an impurity compromised the manufacturing process at a facility in China.

The ministry called on medicine distributors and pharmacies to stop selling all valsartan-based medicines, including VALSARTAN WIN 80 mg and 160 mg, CO-VALSARTAN WIN 80 mg/12.5mg and 16 mg/25 mg and ATENSIL 40 mg, 80 mg and 160 mg.

"Unless another warning is issued, the Medicines Authority and the SPH are adhering to directions given by the EMA and Health Products Regulatory Authority that patients shouldn't stop using this medication haphazardly".

The Pharmaceutical Services Negotiating Committee (PSNC) said batches are being recalled as a "precautionary measure" in an alert published on its website. "We are engaging with healthcare professionals to manage this situation".

The impurity that was found is a probable carcinogen but there's no evidence that it has caused any harm. The medication is also used by patients who have had heart disease or a recent heart attack.

In addition to working closely with the European regulatory network on the investigation, the HPRA is informing all stakeholders including the Department of Health, the Pharmaceutical Society of Ireland (PSI), the Irish College of General Practitioners (ICGP) and other healthcare professionals of this ongoing regulatory action.

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