FDA recalls heart medication valsartan, citing cancer concerns

The U.S. Food and Drug Administration issued a voluntary recall of several medications that contain the active ingredient valsartan, which is used to treat high blood pressure and heart failure.

"This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products, the FDA said in a statement. "However, not all products containing valsartan are being recalled."

Officials say NDMA is classified as a probable human carcinogen—a substance that could cause cancer. They said that finding findings are based on results from recent laboratory tests.

The FDA said the carcinogen's presence is "thought to be related to changes in the way the active substance was manufactured."

"We have carefully assessed the valsartan-containing medications sold in the United States, and we've found that the valsartan 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 Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

Patients already taking the recalled medications should contact their pharmacist or doctor immediately, the FDA says.

To determine whether a specific product has been recalled, patients should look at the drug name and name on the label of their prescription bottle. If the information is not on the bottle, should contact the pharmacy that dispensed the medicine.

The specific medicines recalled are:

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

Explore further

Valsartan cuts microalbuminuria in impaired glucose tolerance

©2018 Miami Herald
Distributed by Tribune Content Agency, LLC.

Citation: FDA recalls heart medication valsartan, citing cancer concerns (2018, July 17) retrieved 25 May 2019 from https://medicalxpress.com/news/2018-07-fda-recalls-heart-medication-valsartan.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
282 shares

Feedback to editors

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more