Ministry recalls some medicines containing valsartan over cancer fears

Health Canada

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.

The recall was triggered after traces of N-nitrosodimethylamine (NDMA) were found in the valsartan used in the affected products.

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Valsartan molecule structure. Drugs containing valsartan are used to treat patients with high blood pressure to help prevent heart attacks and stroke. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured, the EMA said.

The next step for the EMA is to conduct a review of the situation, including determining the levels of NDMA in the products, understanding how this may have affected patients and planning methods to eliminate or reduce such contamination in the future. The drug regulator for the European Union said it would conduct an assessment of the severity of the problem for those who are now taking drugs containing Valsartan. Patients that have had a recent heart attack or heart failure also use these drugs.

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Health Canada indicated it is monitoring the companies' recalls and suggests people taking medicine with valsartan should keep doing so unless their doctor or pharmacist tells them to stop. The 219 drugs containing Chinese-made Valsartan are among 571 available drugs in Korea that contain the ingredient coming from other countries.

Five companies sell drugs containing valsartan in Canada, including Sanis, Sandoz and Teva Pharmaceutical Industries. Pharmacies are therefore instructed to remove the affected medications from their stock and quarantine them.

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Health Canada describes NDMA as "a potential human carcinogen, which means that it could cause cancer with long-term exposure".

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