September 17, 2019

FDA on Friday announced that it has found low levels of a chemical that could cause cancer in some batches of medications commonly used to treat heartburn.

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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.

FDA said since last year it has been investigating NDMA and other impurities found in heart failure treatments, and has issued recalls for those medications because they contained "unacceptable levels of nitrosamines."

FDA finds NDMA in Zantac

FDA on Friday said it also has detected low levels of NDMA in some batches of ranitidine medications, including the brand-name heartburn treatment Zantac. There also are generic versions of the drug, and the medications are available by prescription and over the counter (OTC).

FDA said it still is evaluating whether the levels of NDMA it has detected in ranitidine drugs poses health risks to individuals who have taken the medications. However, the agency said preliminary testing has shown the levels of NDMA found in the heartburn drugs "barely exceed amounts you might expect to find in common foods."

As such, FDA has not issued recalls of Zantac or other ranitidine drugs, but the agency said there are other heartburn medications available that do not contain ranitidine if patients want to stop taking Zantac on their own accord. FDA said such patients should consult their health care providers.

FDA said it will post more information on the matter as it becomes available, and "will take appropriate measures based on the results of the ongoing investigation."

Reaction

Ashleigh Koss—a spokesperson for Sanofi, which sells Zantac—said the company at this time does not plan to recall Zantac. "Sanofi takes patient safety seriously, and we are committed to working with the FDA," Koss said. She added that the OTC version of Zantac "has been around for over a decade and meets all the specified safety requirements for use in the OTC market."

Consumer Healthcare Products Association, which is a trade-group for OTC drugmakers, noted that FDA has not called for a recall. The group said ranitidine drugs "play an important role in helping consumers manage their symptoms and treat heartburn."

Dinesh Thakur, a drug-safety advocate, said FDA's announcement serves as "another good example of how our regulations need to change," because FDA's oversight of raw ingredients that often are made in other countries is too lax. "Things like this will never get caught, unless somebody is actually actively looking for stuff," he said (Weixel, The Hill, 9/12; FDA release, 9/13; Wang, Inside Health Policy, 9/13 [subscription required]; Thomas/Kaplan, New York Times, 9/13).

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