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FDA Requests Removal of All Zantac Products (Ranitidine) from the Market

Zantac Removed From Market by FDA

On April 1, 2020, the FDA requested that all manufacturers of ranitidine, also known as Zantac, immediately remove all prescription and over the counter (OTC) ranitidine drugs from the market. The FDA has advised consumers to stop taking ranitidine products and consult their healthcare provider about other treatment options.

In 2019, independent laboratory studies found N-Nitrosodimethylamine (NDMA), a probable cancer-causing carcinogen, in ranitidine products. This led to the FDA publishing a warning to manufacturers and consumers about NDMA in ranitidine products. The FDA later found that the level of NDMA in some ranitidine product increases over time and when stored at above room temperature.

Click here to read the FDA's full press release regarding Zantac. (https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market)

What is NDMA

NDMA is a type of nitrosamine, which is an impurity that can be found in a variety of medications and even food. According to the FDA, "Everyone is exposed to some level of nitrosamines." The FDA and other international regulatory organizations have set acceptable daily levels for nitrosamines in medications and food, and a person who ingests at or below those acceptable levels is not at risk. However, when humans are consistently exposed to above-acceptable levels of nitrosamines for a long time, they could develop a risk for cancer.

Studies found that the level of NDMA in Zantac increased over time, which is dangerous for a product meant to sit on store shelves. Studies also found that NDMA in Zantac increased when Zantac was stored at above room temperature. This means that consumers who took Zantac for heartburn, GERD symptoms or stomach ulcers could have been exposed to more than the FDA-approved amount of NDMA on a daily basis.

For more information about nitrosamines and medication, visit the FDA's website. (https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications)

What This Means for Consumers

Consumers should talk to their healthcare provider before they stop taking Zantac or other ranitidine products. Healthcare providers will be able to recommend alternatives and manage the transition to new medication. Consumers should NOT abruptly stop taking their medication. Consumers are recommended to stop buying ranitidine prescription and over the counter (OTC) products.

Due to COVID-19, consumers should not bring their old medications to drug take back sites. Consumers should NOT flush Zantac or other ranitidine medications down the toilet. Instead, consumers should follow FDA instructions for disposing of medications safely in the trash which can be found here. (https://www.fda.gov/drugs/disposal-unused-medicines-what-you-should-know/drug-disposal-dispose-non-flush-list-medicine-trash)

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Goldberg Legal's Commitment to You

Goldberg Legal is actively investigating potential claims involving regular Zantac/ranitidine use that may have led to cancer. The following types of cancer are suspected:

· Tier 1 - stomach, small intestine, colorectal, esophageal, liver;

· Tier 2 - prostate (60 years old or younger), pancreatic, Leukemia, NHL, Multiple myeloma of the stomach, colon, intestines, kidneys, bladder or pancreas.

If you or a loved one has regularly taken Zantac or other ranitidine products and has developed cancer, you should know your legal rights and the path forward. Please visit our website at www.smglegal.com or give our office a call at 440-519-9900 to find out how we can bring you relief.

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