FDA Expands Recall of Common Blood-Pressure Medication Valsartan Due to Fear of Cancer-Causing Impurity

by Sokolove Law

On July 13, the Food and Drug Administration (FDA) recalled some medications containing valsartan, a common ingredient used in drugs to treat high blood pressure and help prevent heart failure. Now, the FDA has issued an update, expanding their recall to include additional medications made with valsartan.

The FDA first announced the voluntary recall with a press release after lab tests showed that certain medications contained an impurity of N-nitrosodimethylamine (NDMA), an organic chemical the Environmental Protection Agency (EPA) classifies as a probable carcinogenic, meaning it could cause cancer.

NDMA is used in the making of liquid rocket fuel and is a byproduct of manufacturing pesticides. But as noted by CNN and other media outlets, NDMA can also be created unintentionally through “certain chemical reactions.”

The FDA’s Updated Recall List of Valsartan-Based Medications

Drugs containing valsartan were previously recalled in 21 other countries before the U.S. followed suit in mid-July.

The FDA’s updated recall added these 9 additional NDMA-containing products to its original list:

  • Valsartan/Hydrochlorothiazide (HCTZ) (manufactured by AvKare)
  • Valsartan/Hydrochlorothiazide (HCTZ) (manufactured by Remedy Repack)
  • Valsartan/Hydrochlorothiazide (HCTZ) (manufactured by A-S Medication Solutions LLC)
  • Valsartan/Hydrochlorothiazide (HCTZ) (manufactured by Proficient Rx LP)
  • Valsartan/Hydrochlorothiazide (HCTZ) (manufactured by Northwind Pharmaceuticals)
  • Valsartan (manufactured by A-S Medication Solutions LLC)
  • Valsartan (manufactured by Bryant Ranch Prepack Inc.)
  • Valsartan (manufactured by H J Harkins Company Inc.)
  • Valsartan (manufactured by Northwind Pharmaceuticals)

What Should You Do if You Are Using Valsartan?

If you are currently taking a valsartan-based medication, or if you think that your medication may contain valsartan, check your prescription drug bottle for the name of the drug manufacturer. If your prescription label does not have the company name, you should call your pharmacist or prescribing doctor immediately to get that information and check if FDA placed that manufacturer on their updated recall list.

It is crucial that you do not stop using your medicine, as a sudden change in your prescription routine could be risky; the FDA advises that you continue taking your medicine until your doctor can provide you a safer alternative or a different treatment option, as necessary.

Dr. Mary Ann Bauman of the American Heart Association (AHA) confirmed the FDA’s instructions:

“The key with this is, patients should not stop taking their medication abruptly, that definitely can be harmful. You don’t want to jump to any conclusions on your own about this medication, or any medication for that matter. Definitely talk with your doctor first.”

It is important to note that only medications with the impurity, NDMA, are on the recall list; the FDA also posted a list of valsartan-containing drugs that are not included in this recall.

The FDA’s Next Steps

The FDA reports that it is working with manufacturers of valsartan-containing drugs to make sure that future drugs of this kind are safe and “not at risk of NDMA formation.”

Given the FDA’s ongoing inquiry, the list of recalled valsartan-containing drugs could possibly change as more information becomes available. Visit the FDA’s website to receive up-to-date information on the recall as well as an updated list of products included in the recall and the list of product not included in the recall.

 

FDA Expands Recall of Common Blood-Pressure Medication Valsartan Due to Fear of Cancer-Causing Impurity was last modified: August 10th, 2018 by Sokolove Law