Concern about Zantac first emerged... when American scientists at the Connecticut-based laboratory Valisure studied commercially available samples of Zantac and warned that these contained 'extremely high levels' of a chemical called N-Nitrosodimethylamine (NDMA), thought to cause cancer.
The scientists reported to the US regulator, the Food and Drug Administration (FDA), that the ranitidine in Zantac can degrade over time into NDMA. The risk is particularly high, they added, if the medicine is stored in hot and humid conditions.
The FDA has set a safe limit for daily exposure to NDMA at 96 nanograms. Lab testing by the FDA and Valisure revealed that Zantac samples contained…
An epidemiologist explains what to know.
If you’ve been relying on Zantac for relief, Dr. Farhadi recommends looking into famotidine (Pepcid). “It works in a similar fashion,” she says.
So if you are taking any type of OTC ranitidine, whether it is Zantac or some other version, whether it is tablets or liquids, stop it. Stop it now. If you are worried that your “heatburn will go on,” there are a number of other options. Usually, you should try lifestyle modifications first before opting to take a heartburn medication anyway.
After months of deliberation, the Food and Drug Administration has asked all manufacturers of a particular heartburn medicine known as ranitidine, sold under several brands including Zantac, to withdraw their drugs because “unacceptable levels” of a possible carcinogen may develop in the pills over time.
The agency said it is evaluating whether the low amounts of the chemical, known as NDMA, pose a risk to patients. It said it would make that assessment available publicly as soon as possible.
We spoke with David Light, a co-founder and chief executive officer, about the decision to look for NDMA and why he believes that regulators are failing to characterize the problem properly.
“It’s important to note that there are no data available linking ranitidine to cancer in humans,” Harvard epidemiology professor Joshua Gagne says, “only data showing that some ranitidine products that have been tested contain NDMA.”
Zantac, also sold generically as ranitidine, is the latest drug in which cancer-causing impurities have been found. Regulators have been recalling some blood pressure and heart failure medicines since last year.
Although most drugmakers had already pulled the heartburn products months ago, the agency told consumers they should throw out any over-the-counter medications they still had.
Unfortunately for the buying public, emerging evidence suggests that NDMA can also be created as some pills sit on the store shelf or medicine cabinet. Thus, there is no way to test for its presence in the factory.
An ingredient in Zantac has been linked to cancer - and now patients in the United States are suing drug makers, writes John Naish.