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Alert – FDA asks drug manufacturers to remove all Ranitidine (Zantac) from market for fear of causing cancer

On April 1, 2020, the FDA announced it is requesting pharmaceutical manufacturers withdraw all prescription and over the counter (OTC) ranitidine drugs (commonly known by the brand name Zantac) from the market immediately.

THE FDA noted that this was the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in Ranitidine medications. NDMA is a probable human carcinogen (a substance that could cause cancer). The FDA stated that it has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. The FDA’s announcement was widely covered throughout news media.

The FDA noted that low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and water. These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans. 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 testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the accept daily intake limit.

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