SEMBACH KASERNE, Germany –The U.S. Food and Drug Administration announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.
This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac).
The FDA has determined that 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. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use.
Ranitidine is used for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
According to an FDA news release, the recall recommendation was made because of potential N-Nitrosodimethylamine (NDMA) amounts that exceed levels established by the FDA.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.
Patients who wish to stop taking prescription ranitidine should talk to their health care provider about other treatment options. There are multiple drugs approved for the same or similar uses as ranitidine. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
For more information, visit the FDA website: https://go.usa.gov/xvYUq
As with all medications, excess ranitidine should be disposed of in accordance with local waste management regulations.
Social Sharing