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Taking Zantac? FDA to Investigate Carcinogen in Zantac and Generic Versions

pills-1885550_1920-300x225If you are taking Zantac, you should be aware that the FDA and the European Union are investigating whether the heartburn medication, as well as generic versions of the drug, contain high enough levels of the cancer-causing agent NDMA, (N-Nitrosodimeethylamine), to pose a danger to patients.

Zantac, or Ranitidine, as it is called in generic form, is an antacid and antihistamine used by thousands of people to prevent heartburn and gastrointestinal issues. More troubling is the fact that it is sometimes given to infants suffering from reflux. Now, the medication, which is sold at major pharmacies such as Walgreens, CVS, and Walmart, is under investigation by European and U.S. health regulators.

U.S. drug safety officials became aware of the potential problem when Valisure, a Connecticut based online pharmacy that independently tests every medication it dispenses, alerted the FDA that its testing had found high levels of NDMA, a carcinogen, in Zantac and generic versions of the drug.

Valisure, which had previously detected carcinogens in another recalled drug, Valsartan, has since filed a petition asking the FDA to recall Zantac and its generic versions, claiming that the NDMA levels in the drug are “excessive”. Testing by Valisure has detected levels of NDMA as high as 3,000 micrograms in Zantac pills and generics.

Prompted by these results, Memorial Sloan Kettering has begun researching whether the NDMA levels in Zantac and its generic versions may be linked to an increased risk of cancer. NDMA, which is classified as a “probable human carcinogen” by the EPA, has been linked in some scientific studies to liver cancer, lung cancer, kidney cancer, gastric cancer, and liver damage.

The FDA, for its part, has detected NDMA as high as 17 micrograms in prescription and over-the-counter versions of Zantac but has been unable to give a range of levels found, due to small sample size. So far, the agency is not recommending that people stop taking Zantac and generics, but is advising that other medications are available. According to an FDA spokesperson, the agency does not believe that the levels pose an immediate health risk, but it will continue its investigation and testing of the drug.

We agree with David Light, the chief executive of Valisure, who said: “There’s no acceptable cancer risk for a drug like this.” We urge the FDA and the European Union to fast track their investigations of ranitidine, warn the public of any potential danger, and issue a prompt recall if the evidence warrants it.

In the meantime, until we know the truth, it may be wise to seek out another remedy for heartburn.




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