FDA expands recall of blood pressure drug due to cancer-causing agent

Desiree Burns
August 10, 2018

"It is important to know that not all valsartan products contained NDMA, so pharmacists may be able to provide a refill of valsartan medication from batches that that are not affected by the recall, or doctors may prescribe a different medication that treats the same indications", the FDA states. The recalled drugs were manufactured by Zhejiang Huahai Pharmaceuticals in China and contain a chemical known as N-nitrosodimethylamine (NDMA), which has been shown to increase the occurrence of cancer in animals.

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

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For more information on the recall, visit the FDA's website. "This assessment led to FDA's decision to have these batches recalled", the agency said.

"FDA is working with drug manufacturers to ensure future valsartan active pharmaceutical ingredients (APIs) are not at risk of NDMA formation".

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The Food and Drug Administration has expanded its list of high blood pressure and heart failure drugs that could contain a cancer-causing agent. Novartis still markets Diovan and other branded valsartan-containing drugs like Exforge and Entresto while Teva's Actavis, Stada and Dexcel Pharma are among others selling generics of the drug.

All the US products were pulled from shelves on July 16. Only products contaminated with NDMA are being recalled - not all valsartan tablets. The FDA in its evaluation said that the amount of NDMA in the products being recalled exceed limits that the Environmental Protection Agency deems safe.

Other products that recorded more than 1 billion won of total sales previous year 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).

If you take this medicine, the American FDA has updated its recall and also published a list of Valsartan products not now recalled.

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