Tainted heart medicine Valsartan recalled worldwide

Leslie Hanson
August 10, 2018

Tianyu said (link in Chinese) on Monday that Taiwan's Food and Drug Administration discovered elevated amounts of the impurity - N-nitrosodimethylamine - in valsartan it supplied to the region.

The government has banned local drugmaker Daebong LS from making and selling its blood pressure medication valsartan after a possible cancer-causing substance was found in the drug.

Other products that recorded more than 1 billion won of total sales a year ago include JW Pharmaceutical's Valsaforce (3.71 billion won), Aju Pharmaceutical's Anafurge (1.57 billion won), Myungmoon Pharmaceutical's Exnin (1.12 billion won) and Daehwa Pharmaceutical's Varoforge (1.01 billion won).

The U.S. Environmental Protection Agency has deemed NDMA a probable human carcinogen, or a chemical that could increase the risk of cancer in humans. It said that while no regulatory agency has now placed restrictions on NDMA, it was working with regulators to set an industry standard on NDMA. Scientists from the FDA estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for four years, there may be one additional case of cancer over the lifetimes of those 8,000 people.

If you take this medicine, the American FDA has updated its recall and also published a list of Valsartan products not now recalled. Only products contaminated with NDMA are being recalled - not all valsartan tablets. Ltd. The valsartan was not used in the manufacture of drugs.

The FDA said patients with the recalled products should contact their doctor and their pharmacist if their medication is included on the recall list.

"If a manufacturer detects new or higher levels of impurity, they should take action to prevent changes to the product's safety profile".

Other reports by Iphone Fresh

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