FDA Warns Against Certain Methods for Testing Zantac for Carcinogen

Regulatory NewsRegulatory News | 02 October 2019 |  By 

As the US Food and Drug Administration (FDA) continues to test ranitidine products, including the popular heartburn medicine Zantac, from multiple manufacturers for the carcinogen N-Nitrosodimethylamine (NDMA), the agency on Wednesday warned against the use of a particular testing method.

“FDA observed the testing method used by a third-party laboratory uses higher temperatures. The higher temperatures generated very high levels of NDMA from ranitidine products because of the test procedure. FDA published the method for testing angiotensin II receptor blockers (ARBs) for nitrosamine impurities. That method is not suitable for testing ranitidine because heating the sample generates NDMA,” FDA cautions.

Instead, FDA recommends using an LC-HRMS testing protocol to test ranitidine samples.

“FDA’s LC-HRMS testing method does not use elevated temperatures and has shown the presence of much lower levels of NDMA in ranitidine medicines than reported by the third-party laboratory. International regulators using similar LC-MS testing methods have also shown the presence of low levels of NDMA in ranitidine samples,” the agency said.

FDA also said it will test ranitidine oral solution products and has begun testing samples of other H2 blockers and proton-pump inhibitors.

“To date, the agency’s early, limited testing has found unacceptable levels of NDMA in samples of ranitidine. The agency will provide more information as it becomes available,” FDA said.

Last week, FDA announced the voluntary recall of over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg), labeled by Walgreens, Walmart and Rite-Aid and manufactured by Apotex Corp. Similarly, Sandoz announced a voluntary recall of 14 lots of prescription ranitidine capsules.

FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)


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Tags: FDA, LC-HRMS, NDMA, Zantac

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