FDA expands list of heart failure medications after cancer-causing agent found

Taiwan’s Food and Drug Administration discovered elevated amounts of a cancer-causing impurity in valsartan that Zhejiang Tianyu Pharmaceutical Co. supplied to the island

In our Access members newsletter (paywall) yesterday, we covered the recalls of the blood pressure medicine Valsartan because of a carcinogen found in an ingredient produced by Chinese suppliers Zhejiang Huahai Pharmaceuticals, Tianyu Pharmaceutical, and Rundu Pharma.

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).

NDMA is included in the 2A group - a substance that may act as a carcinogen to humans - according to WHO's International Agency for Research on Cancer (IARC) classification. The discovery of NDMA is believed to be related to how the products were manufactured. 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.

The Ministry of Food and Drug Safety said Monday it has tentatively banned 22 pharmaceutical firms from selling 59 products made by Daebong LS that contain valsartan.

It said they had shipped products to Taiwan but neither appear on the FDA's list of a dozen brands that are being recalled in the U.S. The agency also has a list of products not affected by the recall. Pfizer was the only multinational drugmaker that sold NDMA-detected valsartan-based tablets. Still, the FDA says those can be stopped once another medication is approved by a doctor or pharmacist.

"There are many other substitutes for this medication, and that is an important discussion all patients should have with their physician", Bhusri said.

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