New ‘Impurity’ Prompts Another Round of FDA Recalls on Valsartan

The Food and Drug Administration (FDA) has discovered a new contaminant in valsartan, counteracting a recent study which seemed to put heart medications containing the ingredient in the clear.

In June, the FDA recalled drugs containing valsartan, which is used to treat high blood pressure and heart failure, citing a risk of cancer due to contamination in the drugs’ manufacturing. A study released last week appeared to exonerate the drugs until a second contaminate was found, prompting a wider recall instead.

The FDA found a new “unexpected impurity” in three additional drugs containing valsartan. The announcement of this impurity, NDEA, comes on the heels of a July recall relating to a different contaminate known as NDMA. Both impurities are suspected carcinogens.

All the contaminated valsartan, according to the FDA, was manufactured at Zhejiang Huahai Pharmaceuticals in Linhai, China. Not all valsartan from Zhejiang Huahai was contaminated, however.

On September 12, the medical journal BMJ published a study revealing that the drugs contaminated with NDMA do not pose short-term risks for cancer.

The study analyzed 5,150 Danish patients who had been prescribed drugs containing valsartan since the contaminated batches were first discovered.

“In this nationwide cohort study of Danish valsartan users,” the study said, “we did not see an increased short-term overall risk of cancer associated with the use of valsartan products potentially contaminated with [NDMA].”

The FDA’s most recent findings, however, raise new questions about the contaminated valsartan.

“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,” said Scott Gottlieb, FDA Commissioner.

He continued, “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.”

According to the FDA, not all medication containing valsartan has been contaminated. The contaminated “lots” of medications can be found on the FDA’s website here. If you are taking a medication that contains contaminated valsartan, the FDA recommends continuing to do so until you speak with a doctor or pharmacist.

“Any patient taking valsartan from a recalled lot who has not yet spoken to their pharmacist or doctor should do so promptly,” the FDA said.

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