French drugmaker Sanofi on Friday announced it is recalling the common heartburn drug Zantac in the United States and Canada as a "precautionary measure," after U.S. and European health regulators linked the drug to a probable cancer-causing impurity.
Background: FDA finds cancer-causing chemical in another US drug
FDA last month announced that it had found low levels of a chemical that could cause cancer in some batches of ranitidine medications, including the brand-name heartburn treatment Zantac and generic versions of the drug. The medications are available by prescription and over the counter (OTC).
The chemical, called N-nitrosodimethylamine (NDMA), is the same carcinogen FDA has detected in the common heart drug valsartan. According to FDA, NDMA is an environmental contaminant typically found in foods—including dairy products, meats, and vegetables—and water. NDMA is an impurity the International Agency for Research on Cancer has classified as a probable human carcinogen, meaning it is a substance that could cause cancer.
Earlier this month, FDA said preliminary, limited testing now has detected "unacceptable levels" of NDMA in some samples of ranitidine drugs. The agency said it was continuing to test ranitidine drug samples from various manufacturers and was examining the potential effects that the chemical might have on patients who have taken the drugs. Further, FDA said it asked manufacturers to conduct their own tests on ranitidine drugs to assess whether they contain NDMA, and to send samples of the drugs to FDA for testing by scientists at the agency.
FDA has not issued recalls of Zantac or other ranitidine drugs, but the news sparked some major retailers—including CVS Health, Rite Aid, Walgreens Boots Alliance, and Walmart—to suspend OTC sales of Zantac and other ranitidine drugs. In addition, drugmaker Novartis last month stopped distribution of its ranitidine drugs across the globe. GlaxoSmithKline (GSK) earlier this month announced that it is recalling the common heartburn drug Zantac in all markets as a "precaution."
FDA has said there are other heartburn medications available that do not contain ranitidine if patients want to stop taking ranitidine drugs, though the agency has not recommended that patients stop using the drugs. FDA said patients who want to stop using ranitidine drugs should consult their health care providers.
Sanofi recalls Zantac in US and Canada
Sanofi on Friday announced that it is recalling Zantac in the United States and Canada as a precaution after health regulators found a link between ranitidine medications and carcinogen NDMA. Sanofi said it is collaborating with health authorities to determine the extent of the recall.
Sanofi CEO Paul Hudson at a press conference last week said, "We don't believe there's a risk. But we have to—and are appropriately duty bound to—satisfy the regulators, which we will do, and we'll move on from there."
Sanofi said it is "committed to transparency and will continue to communicate results with health authorities from the ongoing testing, and work with them to make informed decisions based on available data and evidence" (Erman, Reuters, 10/18; Sullivan, The Hill, 10/18).