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Drug RecallsFDA AdvisoryValsartan

Valsartan recalled for cancer link

The heart drug valsartan is being recalled in 22 countries.

It contains a chemical that poses a potential cancer risk. Novartis, the company that originally developed the drug, said Sandoz valsartan and valsartan/HCT film-coated tablets are being recalled since they “do not meet our high quality standards.”

List of countries effected by this recall:

  • Austria
  • Bahrain
  • Belgium
  • Bosnia and Herzegovina
  • Bulgaria
  • Canada
  • Croatia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Lithuania
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Spain
  • Sweden

Products sold in the United States are not affected.

The problem was discovered during tests of batches of valsartan’s active pharmaceutical ingredient (API). The impurity is N-Nitrosodimethylamine (NDMA), an organic chemical that is in a family of potent carcinogens. The chemical has been used to make liquid rocket fuel, softeners and lubricants, among other products. It can also be unintentionally produced through certain chemical reactions and is a byproduct from some pesticide manufacturing, the making of rubber tires or fish processing.

Novartis said that although the amount of the NDMA in the drug isn’t considered a “significantly increased risk to the patients,” patients should talk with their doctors to discuss treatment options as a precaution.