After a year of investigation the US Food and Drug Administration (FDA) has completely withdrawn all ranitidine products from the American market. Studies have revealed levels of a carcinogenic compound can increase in the product over time, particularly when stored at high temperatures.
Early last year concerns were raised after some ranitidine products were found to contain low levels of N-nitrosodimethylamine (NDMA), a known cancer-causing chemical. Frequently sold as a heartburn drug called Zantac, the FDA initially suspected the presence of NDMA was due to some kind of contamination during manufacturing.
By October 2019, many pharmacies in the United States had begun removing Zantac products from their shelves, and the drug’s manufacturer Sandofi voluntarily recalled all over-the-counter products.
Now, based on new information, the FDA has issued a complete withdrawal of all ranitidine products from the American market. Until now it was unclear why different product samples were showing significant variations in NDMA levels, but the FDA has revealed the discrepancies may be due to ranitidine degrading into NDMA over time. So the initial observation of NDMA in the product was not necessarily due to manufacturing contamination.
“New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers,” the FDA states in a new announcement. “The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.”
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, says unsafe levels of NDMA have not been identified in a great deal of tested samples. So at this point there is no suggestion these products have been dangerous to the health of regular users. Instead, the major concern is the discovery that under certain warmer environmental conditions ranitidine can degrade into NDMA, which can lead to certain samples having higher levels.
“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” says Woodcock. “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 suggests anyone using Zantac, or ranitidine products, to immediately stop and throw away those medications. If someone is prescribed ranitidine they should contact their doctor and arrange an alternative medication. The FDA notes no NDMA contamination has so far been detected in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
Source: FDA
