FDA requests all Zantac in all forms get taken off the market for carcinogen problem
The FDA asked all companies that make heartburn, reflux and ulcer drug ranitidine — sold under the brand name Zantac — to pull all forms from the market.
That includes prescription-strength ranitidine; over-the-counter ranitidine, often sold under store brand names; and over-the-counter name brand Zantac.
The agency advises consumers taking ranitidine to stop, dispose of it in the proper manner, and, if in prescription form, check with your doctor or pharmacist for a replacement treatment. Among the suggested OTC replacements are Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole).
As in the numerous ranitidine recalls during 2019, the problem is NDMA (N-Nitrosodimethylamine), classified as a “probable carcinogen.” Third-party testing, the FDA said, showed NDMA levels rise with time under normal storage conditions.
“The agency has determined that the impurity in some rainitidine products increases over time and when stored at higher than room temperatures, may result in consumer exposure to unacceptable levels of this impurity,” the FDA said.
FDA Center for Drug Evaluation and Research Director Janet Woodcock said those high levels weren’t seen in “many samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured.”
This story was originally published April 1, 2020 at 9:47 AM with the headline "FDA requests all Zantac in all forms get taken off the market for carcinogen problem."
