Some generic versions of a common medication used to treat high blood pressure and heart failure, valsartan, contain an impurity that doesn’t meet U.S. Food and Drug Administration (FDA) safety standards. The agency started an investigation after being notified by drug manufacturers about the issue with valsartan, which is an angiotensin II receptor blocker (ARB).
While the investigation continues, the agency has issued a list of valsartan products that are under recall and those that have not been recalled.
The valsartan medications were found to contain a chemical known as N-nitrosodimethylamine (NDMA). The Environmental Protection Agency (EPA) classifies NDMA as a probable carcinogen based on animal studies suggesting the substance raises cancer risk. Levels of exposure in these studies were much higher than those found in valsartan, according to the FDA.
Update: According to an FDA statement issued on September 13, 2018, the latest testing of these products revealed an additional, unexpected impurity in some of the recalled medications. Called N-Nitrosodiethylamine (NDEA), this chemical is a known animal and suspected human carcinogen.
If you take valsartan for your high blood pressure, check the FDA lists. If your medication is on the recall list, contact your doctor but continue taking the drug until your doctor or pharmacist provides a replacement or a different treatment option.
Sourced from: FDA