The U.S. Food and Drug Administration has asked manufacturers of the drug ranitidine (better known as Zantac) to pull all of its prescription and over-the-counter products that contain the drug from the market immediately, the agency announced on Wednesday.

According to a release from the FDA, an ongoing investigation into the drug has found the levels of a contaminant, N-nitrosodimethlylamine (NDMA) (a probable human carcinogen), increases over time, especially when the drug is stored at higher-than-normal temperatures.

“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. “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.”

The FDA has been investigating ranitidine since the summer of 2019 when it urged consumers to avoid using the heartburn medication and urged stores to pull it from their shelves while they continued to examine the levels of the contaminant in the drug.

"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 said the testing indicated that the older the ranitidine product was, the greater the level of NDMA which could raise the level of the contaminant above the acceptable daily intake limit.

People who are using ranitidine should discontinue its use immediately, dispose of the medication properly, and not purchase any more. For those who need to keep treating their condition, the FDA says they should consider using other approved over-the-counter products. The FDA has not found NDMA in other heartburn products, such as famotidine (Pepcid), esomeprazole (Nexium), or omeprazole (Prilosec).

Due to the coronavirus pandemic, the FDA doesn't want people to return the medication to a "drug take-back location," and instead asking people to dispose of the medication by following the instructions contained in the package, or follow the FDA's recommended safe disposal steps on its website.

Photo: Getty Images

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