(Bloomberg) -- Novartis AG’s Sandoz unit said it was halting worldwide distribution of generic versions of the stomach drug Zantac, days after regulators in the U.S. and Europe began investigating the discovery of a likely carcinogen in the medications.
The probable carcinogen that was detected in Zantac and its generics is called NDMA, or N-Nitrosodimethylamine. The same chemical was discovered in generic blood-pressure pills made in China and other countries last year, sparking a recall of multiple versions of those drugs in about 30 countries.
“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,” said Eric Althoff, a spokesman for Novartis. “Our internal investigation is ongoing to determine further details.”
Read more: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S
Novartis shares were little changed Wednesday afternoon in Zurich.
European and U.S. health officials said Friday they were examining NDMA levels in brand-name and generic Zantac, known as ranitidine, and whether it poses a risk to patients. Public-health officials haven’t said whether they have determined how the contaminant may have ended up in the drugs.
Health officials in Canada have asked all companies that make brand-name and generic versions of Zantac to stop distribution of the stomach medicine in that country. The request to stop distribution means that the existing stock of ranitidine products currently available in pharmacies or at retail stores may continue to be sold.
“Current evidence suggests that NDMA may be present in ranitidine, regardless of the manufacturer,” Canadian health officials said in a statement.
Other global regulators didn’t immediately say whether they plan to follow Canada’s action.
“The FDA will take appropriate measures based on the results of the ongoing investigation,” Jeremy Kahn, a spokesman for the U.S. Food and Drug Administration said in an email.
The European Medicines Agency didn’t immediately respond to a request for comment.
Sandoz is recalling its prescription oral version of ranitidine after testing found it contained NDMA levels “above what is considered acceptable,” Health Canada said in a statement Tuesday.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net
To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Timothy Annett
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