Advisory - Several drugs containing valsartan being recalled due to contamination with a potential carcinogen
13 July, 2018, 21:53
The Drug Administration under the Ministry of Health on Tuesday tasked all provincial departments of health and medicine manufacturers and pharmacies to suspend the circulation of all types of medicine containing Valsartan by the China-based Zhejiang Huahai Pharmaceutical Company indicated in a designated list, the Vietnam News Agency reports.
"An impurity, N-nitrosodimethylamine (NDMA), was found in the valsartan used in these products", Health Canada said in a news release on Monday.
Sam Atkinson, director of the Inspection, Enforcement and Standards Division at the Medicines and Healthcare products Regulatory Agency, advised: "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". Health Canada describes NDMA as "a potential human carcinogen, which means that it could cause cancer with long-term exposure".
Explaining how the NDMA may have been introduced into the active substance, the EMA suggested it was likely to have been introduced due to changes in the way the ingredient was manufactured.
"Patients should not stop taking their medicine if it contains valsartan unless they've been specifically instructed to do so by their prescriber or pharmacist". Valsartan has been also used to prevent heart failure.
"We continue to undertake an urgent review of all these products that may pose a low risk to public health". "Patients should contact their pharmacist (s) to see if the drugs they're taking are indeed the affected, recalled valsartan products".
"An investigation into other potentially impacted products is now being undertaken and further updates will be provided as the investigation progresses", the MHRA said.