Novartis AG's Sandoz unit said on Wednesday it was halting distribution of its versions of the drug commonly known as Zantac in all its markets, including the United States and Canada, after contaminants were found in the heartburn drug, Reuters reported.
The Swiss drugmaker's steps follow an investigation by U.S. and European regulators into the presence of low levels of the impurity N-nitrosodimethylamine (NDMA) in ranitidine, the generic name for the drug marketed as Zantac.
The U.S. Food and Drug Administration has classified NDMA as a probable human carcinogen based on results from laboratory tests – however, the FDA is not calling for individuals to stop taking ranitidine at this time. The agency urges patients taking the prescription ranitidine to talk to their health care professional about treatment options.
The agency asks consumers and health care professionals to report any adverse reactions with ranitidine to the FDA’s MedWatch program to help the agency better understand the scope of the problem. Visit the FDA MedWatch site here to complete and submit the form online. The form also can be downloaded from the site and faxed to 800-FDA-0178.