WASHINGTON, D.C. – The Food and Drug Administration (FDA) on Wednesday issued a request for the removal of all prescription and over-the-counter (OTC) ranitidine drugs commonly known as Zantac from the market.
According to the FDA, this is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications including Zantac. The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this 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 also advising consumers taking Zantac 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 health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
The FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert or follow the agency’s recommended steps, which include ways to safely dispose of these medications at home.