FDA now says impurity level in Zantac and other antacids is too high

The FDA is now warning that it has found unacceptable levels of an impurity in ranitidine drugs Zantac and its copies and is providing testing methods to drugmakers to test for it. (Sanofi)

The FDA has changed its tune about the levels of a suspected carcinogen in Zantac and generic ranitidine drugs. Instead of just a little NDMA with a very low risk, the agency says its new “early, limited testing” has found unacceptable levels of NDMA in ranitidine samples.

The FDA is recommending the drugmakers follow its lead and use a low-heat method of testing the antacids and not the high-temperature method used by a “third-party laboratory,” which it says actually generates NDMA and so displays much greater levels of the impurity. It also has asked drugmakers to send samples to the agency for testing. 

RELATED: Zantac and some OTC meds found to contain suspected carcinogen first discovered in blood pressure drugs

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That “third party” was the online pharmacy Valisure, which alerted the FDA and the industry to the presence of NDMA in the heartburn medicines some weeks back. Valisure also filed a Citizen Petition with the FDA seeking to have the agency pull ranitidne drugs from the market and create viable tests for NDMA in them. NDMA is one of three impurities the FDA discovered last year in sartan blood pressure meds that led to a global recall.

Valisure in a statement today said that while contamination of ranitidine products is certainly a concern, it believes the bigger problem is the instability of the ranitidine molecule itself and "the significantly more serious problem is ranitidine's potential to form millions of nanograms of NDMA, a known carcinogen, in the human body." It also said consumers should make sure they don't dump their recalled products in toilets or sinks since it might contaminate drinking water. 

While the FDA has now created a test, it still has not publicly sought recalls. Some drugmakers and three of the largest pharmacy retailers in the U.S. decided not to take any chances. 

RELATED: CVS, Walgreens and Rite Aid pull Zantac and generics as recall spreads around the globe 

CVS this week said it had suspended sales of all Zantac brand and CVS Health brand ranitidine products “out of an abundance of caution.” It was followed by Walgreens and Rite Aid. Walmart jumped on that bandwagon today by suspending sales of those products.

The decisions followed recalls by companies globally. GlaxoSmithKline, the original developer of Zantac, doesn't sell ranitidine products in the U.S. but began pulling them in markets where it does, while Sandoz, Dr. Reddy’s Laboratories and Apotex began retrieving their ranitidine drugs from the U.S. market and elsewhere. The Zantac brand is now owned by Sanofi, which has not recalled it in the U.S., only Canada where regulators have asked for the drugs to be removed. 

In addition to Canada, regulators in South Korean, Germany and Bangladesh have asked for temporary recalls until more testing is done. 


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