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November 17, 2018

Korean authorities to review controversial blood pressure drug valsartan

PUBLISHED : July 12, 2018 - 15:00

UPDATED : July 12, 2018 - 15:09

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[THE INVESTOR] The Ministry of Food and Drug Safety said on July 12 it is testing a method to analyze cancer-causing residue in hypertension drugs’ key ingredient valsartan, manufactured by a Chinese firm, that has sparked recalls in over 20 countries for possible cancer link.

On July 10, the Korean health agency issued recall for a total of 115 drugs containing valsartan from 54 pharma companies to terminate sales or production after Zhejiang Huahai Pharmaceutical voluntarily informed the European Medicines Agency that it had identified N-nitrosodimethylamine, or NDMA, a chemical that might lead to cancer, in its active ingredient. 



“We have arranged an analytic method detect NDMA from the Chinese valsartan. As soon as the verification on the testing method is completed, it will be possible to find out the level of NDMA in these valsartan medicines and its possible impact on patients,” an MFDS official said.

Valsartan is primarily used to treat high blood pressure, heart failure or for patients who have recently had a heart attack.

According to the Ministry of Health and Welfare, some 178,000 people have been prescribed valsartan-containing drugs here.

The MFDS is currently in the process of sharing information and coordination with the European Medicines Agency and other medicine regulators in Switzerland and Germany in relation to the NDMA analysis and risk assessment of valsartan.

The direct damages of pharmaceutical companies caused by the use of the Chinese firm’s valsartan, will be worth about 33 billion won (US$29.22 million) a year, according to data from pharmaceutical market research firm IQVIA Korea.

Recalling companies include ChongKunDang Pharmaceutical, Celltrion Pharm, Kolmar Korea, Daehan New Pharm and Samik Pharmaceutical.

By Park Han-na (hnpark@heraldcorp.com)

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