Recalls issued after carcinogen found in blood pressure, heart failure drugs

The Food and Drug Administration campus in Silver Spring, Maryland is seen in a file photo. (Andrew Harnik | AP Photo)

Washington -- The Food and Drug Administration last week announced recalls of several drugs used to treat high blood pressure and prevent heart failure because they contain a potentially cancer-causing substance.

The drugs all contain the active ingredient valsartan,

. The recall is due to an impurity that has been found in the recalled products.

The impurity, known as N-nitrosodimethylamine or NDMA, is classified as a probable human carcinogen based on lab tests, according to the FDA. The presence of the impurity was unexpected and is thought to be related to some changes in drugs' manufacturing processes.

Not all drugs containing valsartan are being recalled,

. The specific medications and companies involved in the recall are:

  • Valsartan from Major Pharmaceuticals
  • Valsartan from Solco Healthcare
  • Valsartan from Teva Pharmaceuticals Industries Ltd.
  • Valsartan/ Hydrochlorothiazide (HCTZ) from Solco Healthcare
  • Valsartan/ Hydrochlorothiazide (HCTZ) from Teva Pharmaceuticals Ltd.


Patients should look at the drug and company names on the label of their prescription bottles to determine whether their own medications have been recalled, the Herald said. If the information isn't on the bottle, patients should contact the pharmacy that dispensed the drugs.

NDMA is a chemical used to make rocket fuel, softeners and lubricants, among other products, according to CNN. It can be unintentionally produced through certain chemical reactions and is a byproduct of some manufacturing processes.

Animal studies have found the substance can cause tumors in the liver, kidney and respiratory tract, CNN said.

Along with the FDA, 22 other countries previously announced recalls of medications containing valsartan, according to CNN.

The FDA said its continuing to investigate the matter and will provide more information when it is available.

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