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European Medicines Agency

Probable carcinogen in heart drug may have been present since 2012, reveals EMA

An impurity found in valsartan-containing medicines manufactured in China could have been present since 2012, according to the European Medicines Agency (EMA).

At the beginning of July 2018, pharmacies across the EU were advised to recall all batches of valsartan-containing medicines made by Dexcel Pharma Ltd and Accord Healthcare (previously known as Actavis Group), after an impurity was unexpectedly identified as part of Zheijang Huahai Pharmaceuticals’ manufacturing process.

Valsartan is used to treat high blood pressure and heart conditions.

The impurity, N-nitrosodimethylamine (NDMA), is classified as a probable human carcinogen which, according to laboratory test results, could cause cancer with long-term use.

Since NDMA was identified, the EMA has been carrying out a review of valsartan medicines. As part of this, it is gathering details of Zheijang Huahai’s manufacturing processes, following changes introduced in 2012 that are believed to have produced the impurity.

In addition, the EMA is working closely with other national authorities to evaluate whether other medicines containing valsartan, other than those that have been recalled, could also contain NDMA.

It will also consult toxicology experts to gain a better understanding of the impact that use of medicines containing the NDMA impurity may have on patients and establish how long and at what levels patients might have been exposed to NDMA.

However, currently the EMA assures that there “is no immediate risk and patients taking valsartan are advised not to stop their treatments unless they have been advised to do so by their pharmacist or doctor”.

  • On 5 September 2018, a correction was made to this article to highlight that pharmacies were advised to recall only batches of valsartan-containing medicines made by Dexcel Pharma Ltd and Accord Healthcare, not all batches of valsartan-containing medicines.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205197

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