Popular heart drug recalled over possible cancer-causing ingredient

A drug commonly used in medications to treat high blood pressure and heart failure has been recalled over a potentially cancer-causing ingredient, according to the U.S. Food and Drug Administration (FDA).

The FDA recently announced a voluntary recall of the active ingredient valsartan, which is used in several generic medications for high blood pressure and heart failure.

During testing, the drug was found to contain an impurity called N-nitrosodimethylamine (NDMA), which is classified as a human carcinogen, the FDA said, adding that the discovery was "unexpected." The FDA said it believes it is "related to changes in the way the active substance was manufactured."

NDMA is also found in liquid rocket fuels, additives for lubricants and softeners, among other processes, according to the Environmental Protection Agency's website.

The FDA said it will be investigating the levels of NDMA in the recalled products, including the "possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company."

Valsartan products from two companies part of a voluntary recall over a potentially cancer-causing ingredient.

The following are products listed in the recall, according to the FDA:

  • Valsartan from Major Pharmaceuticals
  • Valsartan from Solco Healthcare
  • Valsartan from Teva Pharmaceuticals Industries Ltd.
  • Valsartan/Hydrochlorothiazide (HCTZ) from Solco Healthcare
  • Valsartan/Hydrochlorothiazide (HCTZ) from Teva Pharmaceuticals Industries Ltd.

In a statement, the FDA said it found that the drug "sold by these specific companies does not meet our safety standards."

"This is why we've asked these companies to take immediate action to protect patients," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in the statement.

The FDA encourages patients and health care professionals to report any adverse reaction to the FDA's MedWatch program.

The FDA recommends the following to patients and health care professionals:

  • Because valsartan is used in drugs to treat serious medical conditions, you should not discontinue using any medication containing the active ingredient until you have a replacement.
  • To figure if your specific medication has been recalled, look at the drug and company name on the label of the prescription bottle If the information is not on the bottle, contact the pharmacy that provided it.
  • If your medication is part of the recall, you should contact the health-care professional (either the pharmacist who provided the medication or the doctor who prescribed it) to discuss other treatment options, including another valsartan product not impacted by the recall or an alternative medication.

For more information on the recall, visit the FDA's recall website at FDA.gov.

Spencer Kent may be reached at skent@njadvancemedia.com. Follow him on Twitter @SpencerMKent. Find the Find NJ.com on Facebook.

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