Oneida Center for Rehabilitation and Nursing on the FDA Recall Alert for Zantac Heartburn Drug

Citing levels of a probable human carcinogen that increase over time when stored at higher-than-normal temperatures, the U.S. Food and Drug Administration (FDA) is requesting that manufacturers pull all prescription and over-the-counter products that contain the anti-heartburn drug ranitidine immediately. The most common brand name for this drug is Zantac.

Oneida Center for Rehabilitation and Nursing is answering some frequently asked questions regarding this recall.

What Is the Harm of This Drug?

In the summer of 2019, the FDA became aware of independent laboratory testing that discovered a contaminant called N-Nitrosodimethylamine (NDMA) in ranitidine products like Zantac. They found that the substance increases over time, especially when it’s stored higher than room temperature.

This higher-than-normal exposure to NDMA can increase the risk of cancer in people who use it.

What is the FDA Saying?

“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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a press release. “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.”

What Should You Do if You Take Zantac/Ranitidine?

The FDA is asking all manufacturers of the drug to pull it from the market. If you take Zantac or ranitidine, you are being asked to no longer take it and throw away what you currently have.

People taking prescription ranitidine should talk to their doctor about alternatives.

For those taking the drug in over-the-counter versions like Zantac, the FDA suggests alternatives like famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), or omeprazole (Prilosec). None of these products contain NDMA, according to FDA testing.

To learn more about Oneida Center for Rehabilitation and Nursing and all of the services they offer, visit https://oneida-center.facilities.centershealthcare.org/.