FDA Findings Show Yet Another Impurity In Heart Drug Valsartan


The U.S. Food and Drug Administration has found more "unexpected impurity" in several pills that contain the recalled valsartan drug.

Valsartan is a common ingredient in medication for people who experience high blood pressure and heart failure. However, in July, it has been recalled because public health officials found that it is tainted with N-nitrosodimethylamine or NDMA, an organic chemical used to make rocket fuel and a by-product from manufacturing pesticides. It is also a suspected carcinogen.

In a press release published and disseminated on Thursday, Sept. 13, the FDA told the public about the results of an ongoing investigation around valsartan.

FDA Adds 3 More Recalled Valsartan Drugs

According to the latest round of testing, an additional unexpected impurity was found in three lots of the recalled valsartan drug products by Torrent Pharmaceuticals. The impurity called N-Nitrosodiethylamine or NDEA is also a known carcinogen for animals and humans. All three products have been added to the FDA's growing list of valsartan recalls.

The Zhejiang Huahai Pharmaceuticals was the first to find NDEA in several batches of its valsartan drugs. As a response, the FDA retested all valsartan drugs — both recalled and currently available in the market — for the chemical and found it in three of Torrent Pharmaceuticals' products: 160mg (lot BV47D001) and 320mg (lots BV48D001 and BV48D002) tablets.

Not all ZHP valsartan products are being recalled.

"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," stated Scott Gottlieb, FDA commissioner.

"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."

What To Do If A Patient Has Taken Valsartan

People who have been prescribed with valsartan and are worried about taking contaminated batch should first talk to a pharmacist or their physician. Because not all valsartan drugs are contaminated with NDMA and NDEA, they might be able to offer a replacement.

Public health officials advise that patients continue taking their medication unless told to stop by a professional. Health Canada said that the increased risk of cancer brought by the impurities is from long-term exposure. There is no immediate health risk to anyone who has taken contaminated valsartan drugs.

The FDA is working with Health Canada and the European Medicines Agency to find the root cause of the issue.

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