New FDA data is prompting the agency to request removal of all Zantac and other ranitidine products from stores. This product is contaminated with N-Nitrosodimethylamine (NDMA), which is a probable human carcinogen. Public health officials have found that the impurity in some ranitidine products increases over time, especially when the drug is stored at higher than room temperatures. Rantidine products will no longer be available for over-the-counter or prescription purchase in the U.S.
Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research said in a statement, “The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We didn’t observe unacceptable levels of NDMA in many of the 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. The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.
Low levels of NDMA are in the food we eat and the water we drink. Those levels Arne’t expected to increase the risk of developing cancer. But sustained higher levels of exposure may increase this risk.
In September 2019, the FDA warned the public that NDMA was present in ranitidine at low levels. But this new testing, prompted b information from third-party laboratories, confirmed that the NDMA levels in Zantac increase “significantly” in samples stored at higher temperatures. These temps may be reached during transport and handing by consumers. The older the drug, the greater the level of NDMA
Those conditions may raise the level of NDMA above the acceptable daily intake limit.
The FDA is sending letters to all manufacturers of ranitidine today, asking them to withdraw their product from the market. The FDA is also advising consumers who are taking over-the-counter ranitidine to stop and not buy more.
Testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
Because of the coronavirus pandemic, the FDA is telling consumers not to take these meds to a drug take-back location, but to follow the specific disposal instructions in the medication guide or package insert. The FDA has also published ways to safely dispose of this medications.
