FDA Recalls Heart Medications Containing Valsartan Over Cancer Risk

The U.S. Food and Drug Administration (FDA) announced a voluntary recall of several drugs containing the active ingredient valsartan, which is used to treat high blood pressure and heart failure, due to an impurity, N-nitrosodimethylamine (NMDA).  

NDMA is classified as a probable human carcinogen that could cause cancer based on laboratory findings. The presence of NDMA in valsartan “was unexpected,” according to the FDA, and may be related to changes in the way the active substance was manufactured. 

#FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity: https://t.co/caMjfaCv3O.

— FDA Drug Information (@FDA_Drug_Info) July 13, 2018

Not all products containing valsartan are being recalled—just the generic versions manufactured by Solco, Teva, and Major. 

FDA issued a voluntary recall for medications containing Valsartan due to an impurity. Read more: https://t.co/55MgtwPMqw #FDAUpdate @SGottliebFDA #heartfailure #hypertension pic.twitter.com/gzfC3eGo2G

— ACC Advocacy (@Cardiology) July 17, 2018

Source: FDA