Bulgaria's medicines agency said on July 6 that it was suspending the sale of 62 high blood pressure and heart medications, as part of a Europe-wide recall, after a potentially harmful impurity was found in the active substance manufactured in China. The figure also includes valsartan products not affected by the recall. The review was triggered after the company detected an impurity, N-nitrosodimethylamine (NDMA), a substance classified as "probable cancerogen".
"Alternative valsartan-containing products, that are unaffected by this issue, are available in the United Kingdom".
National authorities across the European Union are now recalling medicines containing valsartan supplied by Zhejiang Huahai while a review investigating levels of NDMA is undertaken.
"The European Medicines Agency and other EU regulators are working together to investigate the extent of the issue and any possible impact for patients". The Medicines and Healthcare Products Regulatory Agency (MHRA) said that patients should be switched to supplies made by other companies. At this time, a precautionary recall of implicated products is the most appropriate action to protect patient health. "We are engaging with healthcare professionals to manage this situation".
"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". The health risk of abruptly discontinuing this medicine is higher than any potential risk presented by the impurity.
The HPRA will provide further updates on this matter as more information becomes available.