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

QA on NDMA in ranitidine

Update [12/4/2019] Over the past several weeks, FDA has communicated about the detection of an impurity known as N-nitrosodimethylamine (NDMA) in common heartburn medications (ranitidine, commonly known as Zantac, and nizatidine) available over the counter or by prescription. We have launched an investigation to understand the cause of this impurity in these drugs and to provide information for patients and consumers who take them. As part of this investigation, we have asked manufacturers to conduct their own laboratory testing to examine levels of NDMA in ranitidine and nizatidine and to send us samples to be tested by our scientists.

Today, we are announcing that we have asked manufacturers of ranitidine and nizatidine products to expand their testing for NDMA to include all lots of the medication before making them available to consumers. If testing shows NDMA above the acceptable daily intake limit (96 nanograms per day or 0.32 parts per million for ranitidine), the manufacturer must inform the agency and should not release the lot for consumer use.

We continue to work with industry and regulatory agencies around the world to determine the reasons for NDMA in these drugs and have developed and posted multiple testing methods to identify NDMA in ranitidine. Our scientists have determined ranitidine does not form NDMA in typical stomach conditions. However, we need further investigation to fully test how ranitidine and nizatidine behave in the human body and have plans to study this. There is also some evidence that there may be a link between the presence of nitrites and the formation of NDMA in the body if ranitidine or nizatidine is also present. Because of this, consumers who wish to continue taking these drugs should consider limiting their intake of nitrite-containing foods, e.g. processed meats and preservatives like sodium nitrite.

Consumers may also consider alternative treatments that are approved for the same or similar uses as ranitidine and nizatidine. To date, FDA’s testing has not found NDMA in Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), or Prilosec (omeprazole).

FDA-published testing method to provide an option for regulators and industry to detect NDMA impurities
The link below is to an FDA-published testing method to provide an option for regulators and industry to detect nitrosamine impurities in ranitidine drug substances and drug products. This method should be validated by the user if the resulting data are used to support a required quality assessment of the API or drug product, or if the results are used in a regulatory submission.
  • LC-HRMS method: an LC-MS method for the detection of NDMA in ranitidine drug substance and drug products
  • LC-MS/MS method: An alternative method for the detection of NDMA in ranitidine drug substance and drug products. This method is based on a triple-quadrupole MS platform.