The U.S. Food and Drug Administration Wednesday announced it is requesting manufacturers withdraw all prescription and over-the-counter ranitidine drugs — commonly known by the brand name Zantac — from the market immediately.
This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine, or NDMA, in ranitidine medications. NDMA has been determined by the FDA to be a probable human carcinogen
The agency has determined the impurity in some ranitidine products increases over time and, when stored at higher than room temperatures, may result in consumer exposure to unacceptable levels of this impurity.
“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. “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 advised consumers using OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more. For those who wish to continue treating their condition, the FDA urged they use other approved OTC products.
Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine. The FDA noted other drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA include famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) and omeprazole (Prilosec).