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Another blood pressure medication recalled over cancer concerns

Several recalls of blood pressure medications have been issued in the last six months due to concerns about a potential cancer-causing impurity.
Credit: Pittman, Travis
A label showing a recalled blood pressure medication due to concerns a possible cancer-causing impurity, Dec. 31, 2018. (Credit: FDA)

Another pharmaceutical company is issuing a voluntary recall of a drug used for blood pressure because it may contain a cancer-causing impurity. It's the latest in a series of recalls since last July.

Aurobindo Pharma USA, Inc. recalled 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP on Monday. You can see a list of all the affected products at this link. Expiration dates range from May 2019 to March 2021.

The impurity is called N-nitrosodiethylamine (NDEA). It is classified as a probable human carcinogen by the International Agency for Research on Cancer. The National Institutes of Health website said NDEA is used as gasoline and lubricant additive, antioxidant and a stabilizer for industry materials.

The company said in Monday's recall there have been no reports of "adverse events" related to the recall.

Despite the possible cancer risk, the company said patients who are using the drugs should continue taking them. That's because the health risk to patients could be higher if they stop without an alternate form of treatment. Patients are advised to contact their doctors about alternatives.

The company said it was notifying distributors and customers by phone and in writing to immediately stop distributing the recalled lots and that instructions for returning the recalled products would be included in the recall letter.

You can use this link to search for recent drug recalls

The FDA told USA TODAY late last year it was investigating the root cause of the problem that is leading to all the recalls.

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