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The U.S. Food and Drug Administration (FDA) is urging manufacturers of the heartburn drug ranitidine, commonly known as Zantac, to immediately remove the product from the market. The withdrawal request is for both prescription and over-the-counter medications that are being investigated for their potential to cause cancer.
The ranitidine medications may contain N-Nitrosodimethylamine (NDMA) - a cancer-causing impurity - which the FDA has determined has increased NDMA levels over time and when stored at higher than normal temperatures, resulting in unacceptable exposure to the impurity.
The FDA said it has sent letters to all manufacturers of the heartburn medication to withdraw their product from the market. The agency is also urging consumers to stop taking any ranitidine tablets or liquid they currently have. They should be disposed of, and no additional ranitidine medications should be purchased.
Consumers that have prescription ranitidine should speak to their healthcare professional have alternative treatment options before stopping the medication. According to the FDA, other drugs such as famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), or omeprazole (Prilosec) are acceptable medications to treat heartburn that do not contain NDMA.
Several recalls have been issued for both prescription and over-the-counter ranitidine as far back as September 2019, with many retailers pulling the products from their shelves. At this time, the FDA said it did not have enough scientific evidence to recommended the discontinuation of these medications, only warning the public about the safety of these medications and urging them to consider alternative products.
Now, the FDA has determined through new testing that NDMA does increase in stored samples at high temperatures, as well as at normal temperatures, which could occur during the distribution and handling of the product. FDA testing found that the older the ranitidine product is, the higher the NDMA level is, increasing the risk of the cancer-causing impurity.
"The FDA is committed to ensuring that the medicines Americans take are safe and effective," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement. "We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science.
"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.
"The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern," she added.
