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) following an urgent investigation into medicines containing valsartan, which are used to treat high blood pressure and heart conditions.
According to a statement from the Ministry of Health, tests detected the appearance of an impurity, probably carcinogenic, in drugs containing valsartan manufactured by Zhejiang Huahai Pharmaceutical.
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 company Zhejiang Huahai found N-nitrosodimethylamine (NDMA) in the valsartan active substance supplied to manufacturers producing some of the valsartan medicines available in the European Union. It is also sometimes prescribed after a heart attack.
The medicines contain the ingredient Valsartan. "Laboratory testing and risk assessments will provide more information as part of this co-ordinated European approach to establish the possible impact on patients who have been taking these medicines and to ascertain if other products may be impacted". The health risk of abruptly discontinuing this medicine is higher than any potential risk presented by the impurity. "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".
European regulators said they were working together to investigate the extent of the issue.
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