Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.


Subscribe or Register

Existing user? Login


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

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Pharmaceutical Statistics

    Pharmaceutical Statistics

    This book on basic statistics has been specifically written for pharmacy students.

    £33.00Buy now
  • Drugs of Abuse

    Drugs of Abuse

    A concise, easy-to-read guide for healthcare professionals who encounter drug abuse.

    £38.00Buy now
  • Adverse Drug Reactions

    Adverse Drug Reactions

    A practical guide to the drug reactions that affect particular organ systems, and the management of these reactions.

    £38.00Buy now
  • English Delftware Drug Jars

    English Delftware Drug Jars

    This beautiful book illustrates the art and history of the collection of English delftware drug jars in the Museum of the Royal Pharmaceutical Society of Great Britain.

    £54.00Buy now
  • Paediatric Drug Handling

    Paediatric Drug Handling

    Written for new pharmaceutical scientists, this book provides a background in paediatric pharmacy and a comprehensive introduction to children's medication.

    £33.00Buy now
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.