Is Valsartan Safe?

On July 13, 2018, the U.S. Food and Drug Administration (FDA) issued a recall on pharmaceuticals containing the active ingredient valsartan. Valsartan is used to treat high blood pressure and heart failure. An impurity that can cause cancer has been found in batches of the ingredient valsartan manufactured in China.

The recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.
However, not all products containing valsartan are being recalled.

Products Being Recalled

The recall does not include all makers and forms of valsartan.

Recall includes: Valsartan or Valsartan/HCTZ manufactured by Major, Solco and Teva.

Recall does not include: Novartis products, such as Entresto.

For information on recalled products, please visit the FDA website.

Information for Patients and Health Care Professionals

The following information is from the FDA website:

• Because valsartan is used in medicines to treat serious conditions, patients taking recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.
• Patients should look at the drug name and company name on the label of their prescription bottle to determine if the product they are taking has been recalled. If this information is not on the bottle, patients should contact their pharmacy.
• If the patient is taking a recalled medication, they should follow the recall instructions for the specific company involved. This information can be found on the FDA website.

Contact Us for More Information

For more information on this topic, other questions related to cardiac care or to refer a patient, please contact Bryan Heart at 402-483-3333.