Distribution of Novartis' generic Zantac halted due to carcinogen concerns

Andrew Cummings
September 20, 2019

The move comes after the US Food and Drug Administration and European Medicines Agency announced earlier this month that tests showed some ranitidine products contained NDMA, which is classified as a probable human carcinogen based on lab tests.

Eight brands of ranitidine medicines - used to treat patients with conditions like heartburn and gastric ulcers - were removed from Singapore shelves for containing a cancer-causing agent.

Novartis said in an emailed statement its step was precautionary and adequate measures "will be implemented in alignment with relevant health authorities as required".

The likely carcinogen found in the drug, ranitidine, is called N-Nitrosodimethylamine, or NDMA. The FDA has also been investigating blood pressure and heart failure medicines known as angiotensin II Receptor Blockers (ARBs) for this carcinogen since past year.

Editor's note: This story has been corrected to make clear that Novartis stopped distributing generic versions of the heartburn medication Zantac.

Over-the-counter ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach.

A distribution halt is different from a recall and means that existing stock of the drugs in pharmacies or stores can still be sold, according to Reuters. Our internal investigation is ongoing to determine further details.

The FDA is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients and said it will share the information when it is available. Numerous recalls have been launched as the FDA found "unacceptable levels" of nitrosamines in those drugs.

Health Canada noted that people are exposed to low levels of the chemical in common foods and drinking water, but it isn't believed to be harmful at low levels. The recalled drugs, which were manufactured in China, had higher levels of the NDMA chemical than USA health officials deemed acceptable.

The authority added that it is working with the companies supplying these medicines and worldwide regulatory agencies to verify the causes of the nitrosamine contamination, and to identify the necessary measures to address the issue.

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