The U.S. Food and Drug Administration has urged to withdraw Sanofi’s heartburn drug Ranitidine as well as its generics from the market with immediate effect for possible contamination. The recall involves all prescription and over-the-counter or OTC ranitidine drugs, commonly known by the brand name Zantac.
The recall includes generic products that contain ranitidine made by Novartis, Endo, Dr. Reddy’s Laboratories, Perrigo, and others.
The FDA said the ranitidine products, which are used to treat stomach acid and ulcers, will not be available for new or existing prescriptions or OTC use in the U.S. FDA is sending letters to all manufacturers of ranitidine asking to withdraw their products.
The decision was taken following an ongoing investigation of a contaminant known as N-Nitrosodimethylamine or NDMA, a probable human carcinogen, in ranitidine medications. NDMA is generally found in water and foods, including meats, dairy products, and vegetables.
In a statement, the heath regulator said it has found that the impurity in some ranitidine products increases over time, when stored at higher than room temperatures. This is likely to result in consumer exposure to unacceptable levels of this impurity.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said, “We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured.”
Independent laboratory testing previously had found the presence of NDMA in ranitidine, but FDA at that did not have enough scientific evidence to recommend to discard its use. The agency in September 2019 had warned the public of the potential risks and to consider alternative OTC and prescription treatments.
Following this, several drug companies in the U.S. had issued recalls for Ranitidine. Sanofi had recalled all Zantac OTC in the U.S., while Dr. Reddy’s, Perrigo, and Sandoz Inc., the generics division of Swiss drug maker Novartis AG, recalled all Ranitidine Tablets.
Retail giant Walmart as well as Walgreens and CVS Pharmacy suspended the sale of OTC Ranitidine medications at their counters.
Woodcock further suggested multiple alternative medications to treat heartburn. FDA said its testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
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