Certain blood pressure and heart medications that contain valsartan have been recalled due to concerns that they may be tainted with N-nitrosodimethylamine (NDMA), a potentially cancer-causing substance.

What is Valsartan?

Valsartan is an oral medication indicated to treat patients suffering from high blood pressure or congestive heart failure. It belongs to a class of drugs called angiotensin receptor blockers (ARBs). By blocking the angiotensin receptor, valsartan causes blood vessels to dilate, thus lowering blood pressure.

The U.S. Food & Drug Administration (FDA) approved valsartan in 1996.

Valsartan is currently off patent and is an active ingredient in a number of generic medications.

Valsartan Side Effects

Common side effects associated with valsartan include:

  • Headache
  • Dizziness
  • Fatigue
  • Abdominal pain
  • Cough
  • Diarrhea
  • Nausea

More serious valsartan side effects include:

  • Hyperkalemia: A condition caused by high levels of potassium in the blood. Severe hyperkalemia can lead to cardiac arrest and death.
  • Impotence
  • Reduced kidney function
  • Allergic reactions
  • Rhabdomyolysis: Inflammation and destruction of muscle.
  • Angioedema: Swelling of soft tissue.

Valsartan Recall

The FDA announced a recall for certain valsartan-containing drugs in July 2018 due to the possible presence of an impurity – NDMA – that may pose a cancer risk.  The agency expanded the recall on August 2nd.

The U.S. valsartan recall came after regulators in 22 countries, including Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta, recalled 2,300 valsartan batches for possible NDMA contamination.

It is important to note that not all valsartan-containing medications are included in this recall.  The FDA has published a complete list of recalled valsartan products, as well as a list of medications NOT INCLUDED in the recall.

The valsartan recall is linked to a Chinese manufacturer, Zhejiang Huahai Pharmaceuticals. The presence of NDMA in the affected medications resulted from a change in the company’s manufacturing process. Those changes were made in 2012, so contaminated valsartan drugs may have been on the market for years.

Patients taking a recalled valsartan medication should not stop using the drug, as the conditions being treated are serious. The FDA has urged these individuals to consult with their doctor as soon as possible to switch to an alternative medication.

What is NDMA?

NDMA is an organic chemical that has been used to make various products, including liquid rocket fuel, softeners and lubricants. It is also is a byproduct from some pesticide manufacturing, as well as the making of rubber tires or fish processing. NDMA may also be unintentionally produced through certain chemical reactions.

According to the U.S. Environmental Protection Agency (EPA), exposure to NDMA has been linked to liver damage. The chemical is also a probable carcinogen.

FDA scientists have estimated that there would be 1 additional case of cancer if 8,000 people took 320 mg of valsartan (the highest possible dose) from the recalled medication batches every day for four years.

  1. FDA (2018) “FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity”
  2. FDA (2018) “FDA updates on valsartan recalls”
  3. EPA (2014) “Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA)”
Last Modified: August 10, 2018

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