Zantac maker Novartis halts drug distribution following FDA cancer concerns

FDA finds cancer-causing chemical Zantac

The maker of the popular heartburn medication Zantac said Wednesday it has stopped distributing the drug 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 Swiss pharmaceutical corporation Novartis said it made a “precautionary distribution stop” of Zantac and all medicines containing ranitidine, the generic treatment for stomach acid and ulcers. 

“Our internal investigation is ongoing to determine further details,” the Novartis spokesman added. 

The decision 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

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