FDA Requests Manufacturers Of Ranitidine (Zantac) To Immediately Remove All Such Products From U.S. Market

On April 1, 2020, the FDA requested manufacturers of ranitidine (Zantaxc) to immediately withdraw all prescription and over-the-counter ranitidine products from the U.S. market due to a contaminant known as N-Nitrosodimethylamine (NDMA) found in the medicines. The FDA determined that NDMA 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 Director of the FDA’s Center for Drug Evaluation and Research stated in announcing the ranitidine recall, “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. 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.”

N-Nitrosodimethylamine (NDMA) In Ranitidine

NDMA is a probable human carcinogen. In the summer of 2019, the FDA became aware of independent laboratory testing that found NDMA in ranitidine. Low levels of NDMA are commonly ingested in the diet (NDMA is present in foods and in 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. The FDA conducted thorough laboratory tests and found NDMA in ranitidine at low levels. At the time, the FDA did not have enough scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines, and continued its investigation and warned the public in September 2019 of the potential risks and to consider alternative OTC and prescription treatments.

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 acceptable daily intake limit.

The FDA advises consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have and to dispose of them properly and not buy more. For those who wish to continue treating their condition, they should consider using other approved OTC products (to date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec)). The FDA advises patients taking prescription ranitidine that they should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA.

Source

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This entry was posted on Friday, April 3rd, 2020 at 5:26 am. Both comments and pings are currently closed.

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