Novartis has halted distribution of generic Zantac

Henrietta Strickland
September 20, 2019

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

In response to Valisure's findings, both the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) acknowledged the potential for contamination and began their own investigations into ranitidine-containing medicine.

"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". It's thought to be unsafe in high amounts, and the levels detected by the FDA in ranitidine are comparable to levels you might find in food. Our internal investigation is ongoing to determine further details.

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

Individuals taking a prescription ranitidine drug, including a recalled product, should not stop taking it unless they have spoken to their health-care provider and obtained alternative treatment, as the risk of not treating the condition may be greater than the risk related to NDMA exposure.

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

Novartis AG's Sandoz division said Wednesday it has stopped distributing generic versions of the popular heartburn medication Zantac worldwide pending investigations from US and European health regulators into a potentially cancer-causing ingredient in both branded and generic versions of the treatment. NDMA is a member of the nitrosamine family of chemicals also found to have contaminated some angiotensin receptor blocker drugs, sparking an uproar that still hasn't died down.

NDMA can cause harm in large amounts, but the levels the FDA found in preliminary tests of ranitidine "barely exceed amounts you might expect to find in common foods", according to a statement last week from Dr. Janet Woodcock, research director for FDA's Centers for Drug Evaluation and Research.

People can report adverse health reactions with ranitidine to the FDA's MedWatch.

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