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April 1, 2020: FDA Requests Removal of All Ranitidine Products (Zantac) from Market

FDA Ranitidine (Zantac) Removal News – The U.S. Food and Drug Administration (FDA) has requested that all products containing Ranitidine (commonly known by the brand name: Zantac) be removed from the market due to an impurity having potential to cause cancer.

Ranitidine (Zantac) Removal Information

On April 1, 2020, the FDA issued a statement requesting that manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is due to the fact that a contaminant known as N-Nitrosodimethylamine (NDMA) was found in Zantac and in other ranitidine medications, per an ongoing investigation.

As a result of the FDA’s immediate market withdrawal request, Zantac and other ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.

The FDA is sending letters to all manufacturers of Zantac and ranitidine products requesting they withdraw their products from the market. Additionally, the FDA is also advising consumers taking Zantac or OTC ranitidine products to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more. Further, for those who wish to continue treating their condition, the FDA has stated they should consider using other approved OTC products.

Patients taking prescription ranitidine are being advised by the FDA 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. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

Per the FDA’s statement:

“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’s Investigation Leading to Zantac Removal

NDMA is a probable human carcinogen (a substance that could cause cancer). In the summer of 2019, the FDA was made aware of independent laboratory testing that found NDMA in ranitidine. Low levels of NDMA are commonly ingested in the diet, for example 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 can potentially 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 agency did not have absolute scientific evidence to recommend whether individuals should continue or stop taking Zantac and other ranitidine medicines. The FDA continued its investigation and advised the public in September 2019 of the potential risks and to consider alternative OTC and prescription treatments.

Further FDA testing and evaluation, aided 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 inadvertently be exposed to during distribution and handling by consumers. The testing also showed that the older the Zantac or ranitidine products are, or the longer the length of time since they were manufactured, the greater the level of NDMA. These conditions could potentially raise the level of NDMA in the Zantac or ranitidine products above the acceptable daily intake limit.

Contact The Weinberg Law Firm for a Free Zantac Lawsuit Case Evaluation

Attorney Eric H. Weinberg has played a significant role in multiple mass tort litigations against corporate pharmaceutical defendants. He has represented plaintiffs in high profile drug lawsuits including Pradaxa, Vioxx, Baycol, and blood clotting products. For a free Zantac or ranitidine lawsuit evaluation, please call us toll free at 1-877-934-6274, or submit the easy-to-use Free Legal Case Evaluation Form. Our phones are answered 24/7.

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