The FDA has issued a voluntary recall of a commonly used heart medicine due to the presence of an impurity linked to cancer.
In a statement, the agency said that lab tests found N-nitrosodiumethylamine (NDMA) in valsartan, which is used to treat high blood pressure and heart failure. According to the Environmental Protection Agency, NDMA was one used in the production of rocket fuel, antioxidants and softeners for copolymers.
“The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured,” the FDA stated.
The voluntary recall will impact batches of valsartan made by Teva Pharmaceuticals, Solco Healthcare, and Major Pharmaceuticals.
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said.
The FDA said that its investigation of the contamination is ongoing.