A generic version of a popular heartburn medication may be contaminated with a cancer-causing chemical.
Drug regulators in both the U.S. and Europe launched an investigation last week that revealed certain medications containing ranitidine — the generic version of Novartis’s Zantac — contained low levels of NDMA, or N-Nitrosodimethylamine, which is a probable carcinogen, according to the U.S. Food and Drug Administration. Sandoz, the generic drug arm of Novartis, has halted worldwide distribution in the meantime. Some versions of Zantac have also been recalled in Europe and Canada, reports the Los Angeles Times.
"A precautionary distribution stop of all Sandoz ranitidine-containing medicines in all our markets will remain in place under further clarification,” Dana Kahn Cooper, a spokesperson for Novartis, told Medscape Medical News. “This includes capsules in the USA. Our internal investigation is ongoing to determine further details.”
The Food and Drug Administration released a statement on Sept. 13 after learning that some ranitidine drugs, “including some products commonly known as the brand-name drug Zantac,” contained low levels of NDMA. “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests,” noted the agency. NDMA is a “known environmental contaminant” that’s found in water and foods, including cured or grilled meats (such as bacon), dairy products and vegetables, according to the FDA.
Ranitidine-containing drugs aren’t the only ones contaminated with NDMA; trace amounts were found in the popular blood pressure medication losartan, leading to its recall last June.
But the FDA doesn’t seem too concerned about the amounts of NDMA found in the heartburn drugs. Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statement: "Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods."
So how concerned should you be if you’re taking an over-the-counter or prescription heartburn medication with ranitidine?
Julie Kennerly-Shah, a pharmacist at The Ohio State University Wexner Medical Center, tells Yahoo Lifestyle: “If you’re actively taking ranitidine, there’s no reason to completely halt the therapy immediately.” And the FDA agrees, saying in a statement that they’re not suggesting people stop taking ranitidine medications at this time.
“However, it is a potential concern,” notes Kennerly-Shah, “and there are alternatives you can purchase over-the-counter.”
If you’re concerned about your over-the-counter ranitidine-containing heartburn drug, look for another effective medication: “If I were a consumer, there is more than one drug on the market and available to treat heartburn,” says Kennerly-Shah. “There are several other medications that are proven to be just as effective. My preference would be to err on the side of caution. And I agree with the precautionary distribution stop until further information is elucidated — because it is a carcinogen.”
For those who wish to discontinue using prescription heartburn medications with ranitidine, Kennerly-Shah echoes the FDA’s recommendation to reach out to your healthcare provider for other treatment options.
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