FDA joins EU in seeking recall of certain Chinese-made valsartan products over potential cancer risk

Recalls of certain drugs containing heart drug valsartan supplied by Zhejiang Huahai Pharmaceutical have spread to the U.S., as the FDA sought voluntary actions to take some affected drugs off the shelves due to the potential cancer risk.

The recall, like the one announced earlier by the European Medicines Agency, is because the API in those drugs was unexpectedly tainted with N-nitrosodimethylamine (NDMA), a substance that could cause cancer.

The recalled finished products in the U.S. include all non-expired generic valsartan sold by Major Pharmaceuticals, Teva and Huahai’s U.S. subsidiary, Solco Healthcare, as well as valsartan/hydrochlorothiazide (HCTZ) made by Teva and Solco. Valsartan’s original developer Novartis previously told FiercePharma none of its valsartan products marketed in the U.S.—branded or generic— are affected.

“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a statement.

In Europe, Novartis is recalling Sandoz’ valsartan and valsartan HCT film-coated tablets in 23 countries. Teva, Stada, Dexcel Pharma and Accord Healthcare are among those affected by the EU recalls. Drugmakers selling valsartan products made of Huahai’s API are also recalling their meds in Japan, Canada, Chinese mainland, Hong Kong and Taiwan. 

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China’s Huahai suspended manufacturing and supply to those markets and informed regulatory agencies after it discovered the residue in its supplies. It attributed the impurity to a new manufacturing process it recently adopted. The FDA said it is currently investigating the levels of NDMA in the recalled products, assessing the effect on patients and working with Huahai to solve the problem in future batches.

NDMA has been classified by the World Health Organization’s International Agency for Research on Cancer as a probable carcinogen to humans. There is ample evidence to prove it is toxic to animals, but not enough data can determine a quantitative risk of cancer in humans.

Based in China’s Zhejiang Province, Huahai is one of the world’s major valsartan API suppliers. According to the company’s disclosures to the Shanghai Stock Exchange, in 2017, it sold CNY 328 million (about $50 million) worth of the ingredient in 2017 and collected $20.4 million from valsartan-containing drugs.

Because valsartan is a common medicine to help patients with high blood pressure and to reduce the chance of heart attack, the FDA suggests patients taking the recalled medicine to continue taking their medicine until a replacement is in place. The agency said its drug shortages team is also trying to ensure an adequate supply of unaffected alternatives.