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Novartis halts distribution of generic Zantac after FDA raises cancer concerns

Novartis halts distribution of generic heartburn medication

Novartis AG's Sandoz division said Wednesday it has stopped distributing generic versions of  the popular heartburn medication Zantac worldwide pending investigations from U.S. and European health regulators into a potentially cancer-causing ingredient in both branded and generic versions of the treatment.

The Sandoz division of the Switzerland-based Novartis said it made a "precautionary distribution stop" of medicines containing ranitidine, the generic treatment for stomach acid and ulcers.  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," a Novartis spokesman said. 

Meanwhile, the French pharmaceutical company that makes Zantac, Sanofi, said in a statement Wednesday "there are currently no plans to stop distributing or manufacturing Zantac or other ranitidine products outside of Canada." The Sanofi statement added that "we are conducting our own robust investigations to ensure we continue to meet the highest quality safety and quality standards."

The Novartis decision to halt distribution of generic ranitidine treatments follows a Friday announcement from the U.S. Food and Drug Administration that the drug contained a "probable" carcinogenic chemical in a type of nitrosamine called N-nitrosodimethylamine, or NDMA.

The federal agency said NDMA is dangerous in large quantities, but the amount found in the heartburn drugs barely exceeds levels found in common foods. For now, U.S. health officials said patients can continue taking Zantac and similar heartburn medications, but prescription patients can consult their doctors if they want to switch to other treatments

NDMA is the same chemical that has been linked to dozens of recalls of prescription blood pressure drugs in the past year, including a commonly prescribed one called valsartan. The recalled drugs, which were manufactured in China, had higher levels of the NDMA chemical than U.S. health officials deemed acceptable. 

Agency officials said the FDA is investigating whether low levels of the carcinogen in heartburn medication is a risk to patients and will post its findings as soon as possible. 

— The Associated Press contributed to this report

Editor's note: This story has been corrected to make clear that Novartis stopped distributing generic versions of the heartburn medication Zantac. It also now includes information that Zantac maker Sanofi has no plans to stop distributing or making Zantac and its generic versions outside of Canada.

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