Don’t take Zantac – it could cause cancer.
That was the message sent by the U.S. Food and Drug Administration on April 1 when it requested that manufacturers withdraw all prescription and over-the-counter ranitidine (brand name: Zantac) drugs from the market immediately.
The FDA is also advising consumers taking ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more. 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).
This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications. 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 over-the-counter use in the U.S.
“We decided that it should not be available to consumers and patients unless its quality can be assured,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
In light of the current COVID-19 pandemic, 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.
The FDA continues its ongoing review, surveillance, compliance and pharmaceutical quality efforts across every product area, and will continue to work with drug manufacturers to ensure safe, effective and high-quality drugs for the American public.
The FDA encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program. Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.