FDA: More Contaminants Found in Recalled Valsartan Heart Drugs

Jack Phillips

A brand of recalled heart failure and blood pressure medication was found to have a second, carcinogenic impurity.

The U.S. Food and Drug Administration (FDA) said that three lots of Torrent Pharmaceuticals’ valsartan drugs have NDEA, known to cause cancer in animals and is believed to be carcinogenic to humans, according to a statement on Sept. 13.

The Torrent drugs were already part of a recall of valsartan products that were pulled due to a possible contamination of NDMA, another impurity that could cause cancer.

The FDA said that a Chinese firm, Zhejiang Huahai Pharmaceuticals, manufactured the NDEA- and NDMA- containing valsartan.

In a statement, the agency said it as well as “the European Medicines Agency have learned” Zhejiang Huahai Pharmaceuticals discovered NDEA in several batches.

“As we continue to investigate the root cause of the impurities found in products that contain valsartan, our scientists are testing these products to better understand these impurities and to ensure they’re not present in other products. We’re also taking steps to make sure we’re providing stringent oversight of manufacturing processes to reduce the likelihood that impurities could be introduced into other products,” said FDA Commissioner Scott Gottlieb in a statement.

A brand of recalled heart failure and blood pressure medication was found to have a second, carcinogenic impurity. (NTD)
A brand of recalled heart failure and blood pressure medication was found to have a second, carcinogenic impurity. (NTD)

He added: “As we expand our investigational efforts, we’ll continue to make sure the public has the most up-to-date information. We’ll also continue to work with global regulatory agencies to learn as much as we can about how these impurities came about and how they may affect patients’ health around the globe.”

The FDA said that it updated a list of drugs (pdf) included in the recall.

“The FDA reminds patients taking valsartan from a recalled lot to continue taking their current medicine until their doctor or pharmacist provides a replacement or a different treatment option. Any patient taking valsartan from a recalled lot who has not yet spoken to their pharmacist or doctor should do so promptly,” the agency said.

And the FDA added that not all valsartan products contain NDMA or NDEA.

Tainted Chinese Products

“There is a lack of trust in medicines made in China now,” Rosemary Gibson, a senior adviser at The Hastings Center and an author of several books on health care issues, told The Epoch Times several weeks ago about the recall.

Zhejiang Huahai Pharmaceutical sold $50 million worth of valsartan in 2017 alone, according to the report, and it didn’t respond to The Epoch Times’ requests for a comment in the report.

“The public wants their medicine to be safe. This carcinogen hidden in valsartan raises the question whether other products that are made in China have been made contrary to the global standard we came to accept,” Gibson added. “We need to view medicine as a strategic asset, just like how we view oil and energy supply,” Gibson added. “A strategic asset is something that will make our country fall apart if we don’t have it.”

Jack Phillips is a breaking news reporter with 15 years experience who started as a local New York City reporter. Having joined The Epoch Times' news team in 2009, Jack was born and raised near Modesto in California's Central Valley. Follow him on X: https://twitter.com/jackphillips5
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