National pharmacy chain CVS is pulling the prescription heartburn drug Zantac, as well as the chain’s own in-house generic version of ranitidine, after traces of a cancer-causing ingredient were found in some of the products, CNBC reports.
Earlier this month, the Food and Drug Administration (FDA) found small amounts of N-nitrosodimethylamine (NDMA), a compound that can cause cancer, in some medicines. Those medicines include ranitidine — which is the generic form of Zantac — as well as certain widely-used blood pressure medications. In the case of the blood-pressure drugs, recalls have led to shortages of the medicines.
In a statement, CVS noted that neither Zantac nor its generic version has been recalled by the FDA, nor is the federal agency recommending that patients stop taking those medicines.
“This action is being taken out of an abundance of caution due to a recent Product Alert from the U.S. Food and Drug Administration (FDA) that ranitidine products may contain a low level of nitrosodimethylamine (NDMA), which is a probable human carcinogen,” the statement reads in part.
Customers who have purchased Zantac or its generic house brand at CVS can return the product to the store for a refund. The store will continue to sell multiple other prescription heartburn medicines, as well as their generic equivalents, when available.
Zantac/ranitidine’s manufacturer, Novartis’ Sandoz division, said that it is halting distribution of Zantac in all its markets, including the United States and Canada.
Meanwhile, the FDA will continue to investigate whether or not the presence of the cancer-causing chemical is a danger to consumers. For now, the agency says that the amounts of the compound being found in ranitidine and other medicines “barely exceed amounts found in common foods,” at least in preliminary tests.
“FDA will take appropriate measures based on the results of this ongoing investigation. Some manufacturers have chosen to stop distribution of ranitidine as a precautionary measure while the FDA and other international regulators conduct their investigations of the NDMA impurity,” the agency said on its website.
The FDA has also developed a testing method that can be used within the industry to test, for themselves, for the presence of NDMA in their drugs.
The agency warns consumers who have had any adverse reactions to the medicine to bring the matter to their health care professional immediately, as well as to report the matter to the FDA. Similarly, the agency asks health care professionals who witness, or receive reports of, adverse reactions to Zantac/ranitidine to report the matter to the agency.