Europe recalls generic heart drug made in China on cancer fears



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.

Valsartan was originally developed by Novartis and the Swiss company marketed it as Diovan, but it is now off patent and is used in a number of generic medicines.

Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack, and heart failure.

However, it is important for people using the medicines "not to interrupt" their treatment, and the ministry recommended patients consult their doctor or pharmacist with any questions.

The impurity that was found is a probable carcinogen but there's no evidence that it has caused any harm.

According to Dr Lorraine Nolan, Chief Executive, HPRA, this is an emerging situation being managed in real time by the HPRA working with the European network of medicine regulators in order to determine the extent of the issue.

There are alternative valsartan-containing medicines and other treatments available to patients.

The Pharmaceutical Services Negotiating Committee (PSNC) said batches are being recalled as a "precautionary measure" in an alert published on its website.

"If you are taking any of the affected valsartan products, it is vital that you do not stop taking your medication but you should get in touch with a doctor or healthcare professional as soon as possible".

"We will communicate the outcome of our investigations and ensure that any other affected products are recalled", he added.

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