This past April, the U.S. Food and Drug Administration recalled all prescription and over-the-counter Zantac from the market immediately as part of an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine --Zantac’s active ingredient. The FDA determined that the NDMA impurity in some ranitidine products can build up over time and when stored at higher than room temperatures. NDMA has been identified as a probable substance that could cause cancer in humans, and its inclusion in Zantac formulations may result in consumer exposure to unacceptable levels of this impurity.
The recall is the result of an FDA investigation into ranitidine that began in the summer of 2019, when the FDA became aware of independent laboratory testing that found NDMA in ranitidine NDMA is present in foods and in water but in low levels not be expected to lead to an increase in the risk of cancer. However, the FDA’s testing and investigation confirmed that NDMA levels increase significantly in ranitidine even under normal storage conditions, but particularly when samples are stored at higher temperatures during transport to market or even through ordinary handling by people taking the medication. The testing further demonstrated the older a ranitidine product is, the greater the level of NDMA. The FDA concluded that any or all of these conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.
As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S. The FDA advises consumers taking over-the-counter ranitidine to stop taking any tablets or liquid, dispose of them properly and not buy more. The FDA further advises patients taking prescription ranitidine to speak with their health care professional about other treatment options before stopping the medicine.
The FDA reports that, so far, its testing has not found the same risks in other drugs approved for similar use as Zantac -- including famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec). However, the FDA’s investigation remains ongoing. In the meantime, if you’ve experienced adverse reactions to Zantac, the FDA encourages you to report the same to the agency’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm. You should also contact an experienced law firm to explore potential legal remedies.
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