Zantac generic shipments halted by Novartis over cancer fears
Sandoz, a unit of Switzerland-based pharmaceutical giant Novartis, halted the distribution of generic versions of its heartburn medication Zantac, in the wake of the U.S Food and Drug Administration's announcement on Friday that low levels of a likely carcinogen were found in it.
The FDA said in a press release that "it has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables."
Ranitidine is a drug that decreases stomach acid and soothes heartburn. The FDA said it was working to figure out how NDMA got into the ranitidine in this case, but has not issued a recall, nor has it called on users to stop taking the drug.
"Patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options," the FDA said in a press release. "People taking OTC ranitidine could consider using other OTC medicines approved for their condition."
According to Fox 11 Los Angeles, a Novartis spokesperson said: "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 USA."
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Novartis did not return FOX Business' request for comment at the time of publication.