FDA recalls blood pressure medication containing valsartan

What you need to know if you are taking a recalled medication

The U.S. Food and Drug Administration (FDA) has announced a voluntary recall of several medications containing an active ingredient known as valsartan. The ingredient is used to treat high blood pressure and heart failure. The recall is due to an impurity, N-nitrosodimethylamine (NDMA), found in the recalled products.

“The recalled medication remains effective — that is not the concern,” said John S. Harris, M.D., cardiologist with Norton Heart & Vascular Institute. “One ingredient in the medication has been classified as a probable human carcinogen, meaning it contains a substance that could cause cancer. The FDA wants to conduct additional testing before continuing to have it prescribed to patients.”

Before you toss your medication, the FDA urges you to wait. The medication is treating serious medical conditions associated with the heart and vascular system. You should continue to take your medication until you can consult your pharmacy for a replacement medication that isn’t on the recall list.

“I agree with the FDA’s recommendation to continue to take the medication,” Dr. Harris said. “Stopping medication for high blood pressure or heart failure can be problematic. It can lead to minor symptoms, such as headaches, dizziness and elevated blood pressure. In extreme cases, hypertension can lead to stroke, heart attack or even death.”

If you are not sure if your medication is being recalled, here are a few tips to find out:

  • Look at the drug name and company name on the label of your prescription bottle. If the information is not on the bottle, contact your pharmacy.
  • If you are taking one of the recalled medications, follow the medication recall instructions provided by the company that manufactures your medication. Your pharmacy can help you find that information.
  • Contact your health care provider to discuss a new treatment plan.

It’s important to note that not all medications containing valsartan are being recalled. The voluntarily recalled medications and manufacturers include:

  • Valsartan made by Major Pharmaceuticals
  • Valsartan made by Solco Healthcare
  • Valsartan made by Teva Pharmaceuticals Industries Ltd.
  • Valsartan/hydrochlorothiazide (HCTZ) made by Solco Healthcare
  • Valsartan/hydrochlorothiazide (HCTZ) made by Teva Pharmaceuticals Industries Ltd.

In a statement on its website, the FDA encourages patients and health care providers to report any adverse reactions to the FDA’s MedWatch Program.


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