April 01, 2020
Following numerous individual recalls, the US Food and Drug Administration (FDA) has announced it is requesting that all manufacturers withdraw prescriptions and over-the-counter (OTC) ranitidine products from the market.
The FDA has been investigating the contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). Based on their investigations, the FDA found that the NDMA in some of these products increases over time, and when the product is stored at higher room temperatures, consumers may be exposed to unacceptable levels of the impurity.
Based on these investigation findings, the FDA’s immediate withdraw request was created. According to the agency, these products will not be available for new or existing prescriptions or OTC use in the US.
“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. 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,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
The FDA is now sending letters to all manufacturers to remove these products, and the agency is advising consumers taking the OTC versions to stop taking any tablets or liquid they currently have. For consumers who still wish to continue treating their condition, the FDA suggests using other approved OTC products.
As of today, the FDA’s testing has not found NDMA in the following:
- famotidine (Pepcid);
- cimetidine (Tagamet);
- esomeprazole (Nexium);
- lansoprazole (Prevacid); or
- omeprazole (Prilosec).
“The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern,” Dr Woodcock expressed.
The US Food and Drug Administration. FDA Requests Removal of All Ranitidine Products (Zantac) from the Market [press release]. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market. April 1, 2020.