FDA recalls heart failure, blood pressure drugs due to cancerous contaminant

The FDA announced last week a voluntary recall of several high blood pressure and heart failure medications containing valsartan due to a cancerous impurity.

Some valsartan drugs were found to contain N-nitrosodimethylamine (NDMA), a compound that is classified as a probable human carcinogen.

Not all drugs containing valsartan were recalled, the FDA noted. Teva Pharmaceuticals (NYSE:TEVA), Solco Healthcare and Major Pharmaceuticals recalled all lots of non-expired drugs that contain valsartan supplied by a third-party company.

“When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications,” FDA commissioner Dr. Scott Gottlieb said in prepared remarks.

Patients taking valsartan-containing medicines should keep taking the drug until they have a replacement product, the FDA added.

“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,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, added.

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