FDA requests removal of all ranitidine from market due to impurity
As a result of the immediate market withdrawal request, ranitidine medications, commonly known by the brand name Zantac, will not be available for new or existing prescription or over-the-counter use in the U.S.
The FDA announced on April 1 that it is requesting manufacturers to immediately withdraw all prescription and over-the-counter (OTC) ranitidine medications from the market due to potential contamination with N-nitrosodimethylamine (NDMA), a probable carcinogen.
The call to action is the latest step in the FDA's ongoing investigation of NDMA in ranitidine, a histamine-2 receptor antagonist commonly known by the brand name Zantac. The impurity in some ranitidine products increases over time and when stored at higher than room temperatures, which may result in consumer exposure to unacceptable levels of NDMA, the FDA said in a press announcement. As a result of the immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.
The FDA is advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly, and not buy more; those who wish to continue treating their condition should consider using other approved OTC products. Patients taking prescription ranitidine should speak with their clinicians before stopping the medicine, as there are several drugs approved for the same or similar uses that do not carry the same risks from NDMA. For example, the FDA's testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), or omeprazole (Prilosec).