Some drugs containing valsartan recalled due to potential carcinogen

Leslie Hanson
July 13, 2018

Valsartan medicines are used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke.

N-nitrosodimethylamine (NDMA) has been detected in the valsartan active substancemanufactured by Zhejiang Huahai Pharmaceuticals. The designation is given when there is limited evidence of the agent's carcinogenicity on humans. The agency also said that everyone that takes medication which contains valsartan should continue taking it unless their doctor or pharmacist tells them to stop.

The valsartan active ingredient from the facility in China has been used by various pharmaceutical manufacturers to produce valsartan-containing medications in Europe, some of which are available on-island.

The announcement follows news last week that the European Medicines Agency launched a recall and review of valsartan-containing drugs.

Health Canada also advises anyone taking any medication containing valsartan to speak to their pharmacist to find out if their medicine is being recalled. The original, Diovan, is now the third-most popular hypertension drug in Korea. It initiated on-site investigations of 82 companies to check whether the drugs contain NDMA.

"I'm astounded that carcinogens were found in medicine that is supposed to fix my disease", one patient said. Patients that have had a recent heart attack or heart failure also use these drugs.

On Saturday, the Health Insurance Review & Assessment Service revised its Drug Utilization Review, a computerized pharmaceutical review system that oversees prescriptions, to display an on-screen warning when doctors try to prescribe a banned drug on their computers.

The review being performed by the EMA will look at the levels of NDMA in the affected valsartan medicines, any potential impact that may affect patients who have already been taking the medicines and what specific measures should be taken to lower or remove the impurity from any future batches produced by the Chinese company.

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