U.S. FDA says carcinogen not found in alternatives of Zantac and its generics


Oct 23 (Reuters) - The U.S. Food and Drug Administration said on Wednesday that alternatives to popular heartburn drug Zantac and its generic versions, known chemically as ranitidine, have not been found to contain the probable cancer-causing impurity that ranitidine has been linked to. (http://bit.ly/2oYJ1Vz)

U.S. retailers Walmart Inc WMT.N, CVS Health Corp CVS.N Walgreens Boots Alliance Inc WBA.O and Rite Aid Corp RAD.N have all removed Zantac off their shelves after some drugs containing its key ingredient ranitidine were found to have traces of the impurity, N-nitrosodimethylamine (NDMA).

Early tests of alternatives to over-the-counter ranitidine, such as Pepcid, Tagamet, Nexium, Prevacid and Prilosec show no NDMA, the agency said.

The FDA said earlier this month it found unacceptable levels of NDMA in drugs containing ranitidine. The regulator asked ranitidine makers to conduct their own testing to assess levels of the impurity and to send samples of their products for testing by the agency.

French drugmaker Sanofi SA SASY.PA last week said it would recall Zantac in the United States and Canada.

NDMA had previously been found in some blood pressure medicines from a class of drugs known as angiotensin II receptor blockers, or ARBs. The potentially cancer-causing impurities are believed to have been introduced by recent changes in the manufacturing process for the drugs.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shailesh Kuber)

((manojna.kalyani@thomsonreuters.com; within the U.S. +1 646 223 8780, outside the U.S. +91 80 6749 1692;))

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


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