The FDA Issued An Immediate Warning To Stop Taking This Popular Antacid

Henrietta Brewer
April 4, 2020

The experts determined that a contaminant and probable carcinogen called N-Nitrosodimethylamine (NDMA) found in ranitidine meds can increase over time when not properly stored. Based on these findings, the FDA concluded that the levels of NDMA may increase to levels above the acceptable daily intake limit.

"We didn't observe unacceptable levels of NDMA in numerous samples that we tested", said Janet Woodcock, MD, director of the Center for Drug Evaluation and Research, in a statement.

"New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers", the FDA states in a new announcement.

"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 USA", the regulator announced.


Early past year concerns were raised after some ranitidine products were found to contain low levels of N-nitrosodimethylamine (NDMA), a known cancer-causing chemical.

The FDA also said consumers taking over-the-counter ranitidine should stop taking the drug and not buy more, and those taking prescription ranitidine should ask their doctor about other options before discontinuing treatment.

"Our tests in lab conditions seem to pretty clearly show that the drug is able to degrade into NDMA by itself, either in the tablet or actually in the human body", Valisure founder and CEO David Light recalled in a conversation with NPR last fall. As such, the pharmacy petitioned the FDA to request a recall of all products containing ranitidine.

Because of the coronavirus pandemic, the FDA warns people with leftover medications not to return them to a drug take-back facility. 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. Currently, the FDA has not found NDMA in famotidine, cimetidine, esomeprazole, lansoprazole, or omeprazole.


Federal regulators are also recommending that patients with over-the-counter versions of the drug stop taking them, and that those with prescriptions consult their doctors about switching.

Consumers who wish to continue treating their condition should consider using other approved medications, according to the FDA.

The agency says it will continue 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".


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