Worldwide Distribution of Generic Zantac Halted Over Carcinogen Concerns
By R.J. Johnson - @rickerthewriter
September 18, 2019
Days after the U.S. Food and Drug Administration (FDA) announced they discovered some common heartburn medications, like generic Zantac, contained low levels of impurities that could lead to cancer, the company responsible for the worldwide distribution of the generic version of the stomach drug said they were halting all orders amid the investigation into the heartburn drug.
According to a release from the FDA, regulators discovered low-levels of a probable carcinogen called NDMA, or N-Nitrosodimethylamine. That chemical was also discovered in other generic pills, such as blood-pressure medication made in China and other countries last year, leading to a frantic recall.
Novartis AG's Sandox unit said they would halt distribution of the generic Zantac while health officials determine the health impact of NDMA to patients.
“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.”
Public health officials have not said how the possible carcinogen may have ended up in the medication. The agency added that people who use the generic Zantac can continue to do so after preliminary tests showed that levels in the medication were not much higher than what people find in their foods
"Patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health," the FDA said in a statement. "Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods."
Health officials in Canada requested that the makers of the drug stop distribution in their country on Tuesday while the investigation continues. The distribution halt does not mean the medication will be taken off of store shelves, only that it will not be replaced once stores run out.
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