Recall Of Blood Pressure Meds Over Ingredient Botch
10 July, 2018, 21:41 | Author: Kara Nash
Valsartan is an important prescription medicine used to treat high blood pressure and heart failure.
The impurity was identified in relation to the manufacturing process in a valsartan active substance.
The impurity (N-nitrosodimethylamine), which could be carcinogenic, is a result of a change in the manufacturing process.
Sam Atkinson, MHRA's director of the Inspection, Enforcement and Standards Division, said: "People taking valsartan medication affected by this recall are advised to not stop taking their medication, but to speak to their doctor or healthcare professional who can advise on alternative treatment".
The HPRA says not all valsartan medicines are affected and is reassuring patients that other treatments are available.
A review underway by the European Medicines Agency (EMA) and national agencies focused on medicines containing valsartan manufactured by China's Zhejiang Huahai Pharmaceuticals, the medicines agency said.
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.
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. At this time, a precautionary recall of implicated products is the most appropriate action to protect patient health.
"Unless another warning is issued, the Medicines Authority and the SPH are adhering to directions given by the EMA and Health Products Regulatory Authority that patients shouldn't stop using this medication haphazardly".
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