Carcinogen concerns prompt Sandoz to halt global distribution of heartburn drug

Sandoz, the generic arm of Novartis, is stopping worldwide distribution of its heartburn medicine that contains high levels of a cancer-causing impurity, according to STAT.

The move to stop distributing Zantac comes just a few days after regulators in the U.S. and Europe flagged a cancer-causing impurity in the drug. Zantac, also known by the generic name ranitidine, decreases the amount of acid created by the stomach. 

The probable human carcinogen found in the drug is N-nitrosodimethylamine. The same carcinogen was also detected last year in blood pressure pills, which prompted hundreds of recalls. 

Sandoz said the measure to halt distribution is "precautionary" and it is working to gain clarification from regulators.

"A precautionary distribution stop of all Sandoz ranitidine-containing medicines in all our markets will remain in place under further clarification, this includes capsules in the U.S.," Eric Althoff, a spokesperson for Novartis, told Bloomberg.  "Our internal investigation is ongoing to determine further details."

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars