Zantac NDMA levels: Potentially hazardous chemical found in popular Zantac heartburn pill – CBS News poll

New York – The nation's three largest pharmacy chains – Walgreens, Rite Aid and CVS – have stopped selling Zantac and its generic alternative. Heartburn drug used by millions was withdrawn after the Food and Drug Administration (FDA) warned this month that it could contain potentially dangerous impurities. But a CBS News poll reveals that it may not be just a "impurity" ̵[ads1]1; but something much more serious.

At a Connecticut lab, called Valisure, scientists test drugs from their own online pharmacy to look for purity and quality. [19659002] Last spring, they decided to analyze a few heartburn medicines to see if they contained a chemical called NDMA, a likely carcinogen . The same chemical had led to recalls of some blood pressure pills in 2018.

One medication stood out: Zantac and its generic version, Ranitidine. It had high levels of NDMA.

"Ranitidine, the active ingredient in Zantac, seems to us to be a fundamentally unstable molecule," Valisure CEO David Light told CBS News.

Light told the FDA and suspects that the problem is not just an impurity, but what happens to the pill inside the body.

"Under a variety of conditions – the conditions in the laboratory, the conditions of the human body – it can break down and then form a carcinogen, NDMA," Light said.

The possibility that Ranitidine could be converted to NDMA in the body was proposed three years ago in research published by Stanford University professor William Mitch and his colleague, Teng Zeng of Syracuse University.

In a small study, 10 volunteers were given a tablet of Zantac. Urine testing found NDMA levels more than 400 times greater than the FDA considers acceptable – even after adjusting for a new FDA protocol for measuring NDMA, Mitch received similar results.

"What we hoped was that someone else would eventually pick up the results that are in the pharmaceutical field," Mitch explained.

CBS News asked if they did. "As far as I know, not yet, but maybe this will spur them on," Mitch answered.

In September, three months after Valisure first notified the FDA of its findings, the agency issued a safety alert and said its own testing found "low levels" of NDMA in Ranitidine. It now calls these levels "unacceptable," and told CBS News that it is now investigating what happens to Ranitidine in the body after being exposed to stomach acid.

"What we have requested is for complete recall of all Ranitidine products – brand, generic does not matter – does not matter who made it or what part number it is," Light said.

Zantac's manufacturer, Sanofi, told CBS News that Mitch's study has limitations and that the company is working closely with the FDA and doing its own "robust testing." While Zantac is still on sale, some generic manufacturers have provided voluntary recalls.

Is there a link between Zantac and cancer?

No, but Memorial Sloan Kettering – one of the world's best cancer centers – has removed Ranitidine from its pharmacy shelves when examining if there is evidence that patients taking Ranitidine are more susceptible to certain cancers. If you are taking Zantac, contact your doctor because there are many options for treating heartburn.