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Amid mounting concerns about the cancer risk from Zantac, due to carcinogenic chemicals recently found in the popular heartburn drug, a recall has been issued for the brand-name, over-the-counter (OTC) version of the widely used medication.
Weeks after a number of generic drug makers ceased distribution of their products, and most major pharmacies decided to pull all versions of the heartburn drug from store shelves, Sanofi announced a Zantac OTC recall late last week, citing possible contamination with the chemical impurity N-nitrosodimethylamine (NDMA).
Zantac (ranitidine) has been on the market for decades, and is regularly used by millions of Americans for treatment of heart burn and acid reflux. However, increasing evidence suggests the active ingredient ranitidine is inherently unstable, and may convert to NDMA when stored at high temperatures, such as in a car, or inside the human stomach.
The problem was first reported in the U.S. by the online pharmacy Valisure, which filed a citizen’s petition calling for a Zantac recall in September. Shortly after, the FDA issued a warning about the potential Zantac risks, indicating that the agency is continuing to investigate the issue.
Sanofi said an evaluation of its own products began at the request of the FDA. The company claims that preliminary test results have been inconsistent, and it is still trying to determine the extent of the problem.
According to independent testing by Valisure, levels of NDMA in certain Zantac tablets were in excess of 3,000,000 nanograms (ng) per 150 mg tablet, which is 26,000 times higher than the FDA’s permissible daily intake for the chemical.
Excessive levels were detected across all brands of Zantac and all lots, and Valisure indicated research dating back 20 years has included warning signs about potential problems with the drug.
In the United States, a number of individuals are now investigating potential Zantac lawsuits, involving allegations that exposure to NDMA in the drugs caused them to develop bladder cancer, stomach cancer, small intestine cancer, colorectal cancer, esophageal cancer and other injuries.
Plaintiffs allege that the diagnosis could have been avoided if the drug makers had disclosed the potential Zantac cancer risk, as other alternative heartburn treatments would have been used. Valisure testing confirmed that no detectable levels of NDMA were found in eight other popular alternatives to Zantac, including Tagamet, Pepcid, Prilosec, Nexium, Prevacid, Protonix, AcipHex and Dexilant.