UK, EU issue valsartan recall

THE European Medicines Agency is reviewing some medicines containing the active ingredient valsartan, after an impurity was detected by Chinese manufacturer Zhejiang Huahai Pharmaceuticals.

The company supplies the active substance to several manufacturers producing some valsartan medicines available in the EU.

Similarly British pharmacies are being advised to recall all batches of valsartan containing medicines made by Dexcel Pharma Ltd and Accord Healthcare (previously known as Actavis group).

The UK Medicines and Healthcare products Regulatory Agency (MHRA) said the move follows an “urgent investigation” into medicines containing valsartan used to treat high blood pressure and heart conditions.

“A recall is underway across Europe following recent and emerging information that an impurity has been identified as part of the manufacturing process in a valsartan active substance manufactured at one facility based in China,” the MHRA said.

A change in the manufacturing process has meant the introduction of impurity N-nitrosodimethylamine (NDMA), which has been classified as a probable human carcinogen.

Patients are being told not to stop taking their medication but get in touch with a doctor as soon as possible, because alternative valsartan products unaffected by this issue are still available.

Pharmacists in Europe and the UK are being advised to check whether they are currently holding stocks of affected batches of valsartan medicines, and quarantine them.

The European Medicines Agency confirmed it was investigating the levels of NDMA in the affected valsartan medicines, the possible impact on patients who have been taking them, and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.

The review is also considering whether other valsartan medicines may be affected.