More Firms Admit Drug Contains High Levels of Cancer-Causing Impurity

FDA expands valsartan blood pressure medication recall

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

It has found some domestic valsartan produced by Daebong LS contained an impurity known as N-nitrosodimethylamine (NDMA) which can cause cancer.

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It said FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches every day for the full four years, there may be one additional case of cancer over the lifetimes of those 8,000 people. "This assessment led to FDA's decision to have these batches recalled", the agency said. 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.

The U.S. Food and Drug Administration has expanded its recall of a commonly used type of heart drug because some of the products may contain a potentially cancer-causing chemical.

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All the US products were pulled from shelves on July 16. Pfizer was the only multinational drugmaker that sold NDMA-detected valsartan-based tablets. "The agency reminds manufacturers to thoroughly evaluate their API manufacturing processes, and changes to those processes, to detect any unsafe impurities", said the FDA in a statement.

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

Doctors and the FDA advised people who are taking valsartan from a recalled batch to continue taking their current medicine until their doctor or pharmacist provides a replacement or a different treatment option.

Not all valsartan-containing medications have been recalled, however, and those also are listed on the FDA's website.

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