Heartburn Drugs and Cancer: What Are the Risks?

Sept. 26, 2019 -- Doctors write more than 15 million prescriptions for the heartburn drug ranitidine (Zantac) each year. Countless more patients buy it over the counter. If a bombshell petition filed with the FDA is correct, all those people might need to find another medication.

The claim: Ranitidine may be prone to breaking down into a cancer-causing substance. FDA testing found the impurity in generic versions and in brand-name Zantac. Already, one major manufacturer has recalled its version of the drug, and another has ceased distribution. Canada has asked all drugmakers to stop distribution there, until they can prove their products don’t contain it.

One thing is for sure: Laboratory testing of the drug found the carcinogen n-nitrosodimethylamine (NDMA). But we don’t know yet what caused the contamination. Ranitidine may simply be unstable and likely to break down, forming NDMA on its own. If this is the case, eventually the drug could be taken off the market. Or NDMA may appear when generic versions of the drug are made in countries with lax quality control, which allows contaminants to sneak in.

Here’s what you need to know and what you can do about it.

Earlier this year Valisure, an online pharmacy that tests all medications before dispensing them, found carcinogens in blood pressure medications. Now they’ve found a different one, NDMA, in ranitidine. It appeared in every batch they tested, from every manufacturer, and often at astonishing levels. The FDA’s permissible daily intake limit is 96 nanograms. Valisure said it followed an established testing protocol and found quantities in excess of 2 million nanograms per tablet. When they adjusted their testing methods to copy conditions inside the human stomach, they found around 300,000 nanograms per tablet -- less, but still more than 3,000 times higher than the FDA’s limit.

“Our finding is that this is an inherent instability of the ranitidine molecule. It just falls apart into NDMA,” says David Light, CEO of Valisure. “And this isn’t just Valisure yelling about something we happened to find. The foundation of this concern has been around for decades. We’re really just connecting the dots.”


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