The Food and Drug Administration (FDA) is requesting the immediate removal of all prescription and over-the-counter (OTC) ranitidine products as new data suggest an increased risk to the public due to the contaminant N-Nitrosodimethylamine (NDMA), a probable human carcinogen.
According to the results of tests conducted by the Agency, NDMA levels in ranitidine products can increase over time under normal storage conditions; higher levels of NDMA were associated with older ranitidine products (the length of time since the product was manufactured). In addition, NDMA was found to increase significantly in ranitidine samples stored at higher temperatures. Under these conditions, patients may be exposed to unacceptable levels of NDMA.
“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,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
The FDA is sending letters to all manufacturers of ranitidine requesting its withdrawal from the market. Consumers are advised to discontinue taking any over-the-counter (OTC) ranitidine and should consider alternative OTC medications. Healthcare professionals should discuss alternative treatment options with patients currently taking prescription ranitidine. The following medications have not been found to contain NDMA: famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
Healthcare professionals and patients can report adverse events associated with these products to the FDA’s MedWatch Program.
For more information visit fda.gov.