Zantac is the brand name for the antihistamine and antacid ranitidine, an H2 (histamine 2) blocker. Pharmacies and stores sell ranitidine over the counter and by prescription as medication to prevent and relieve heartburn. However, Ranitidine medicines, including Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA). The Environmental Protection Agency (EPA) has classified NDMA as a “B2 probable human” carcinogen, which means NDMA can cause cancer in animals, but the EPA has not yet definitively determined it to cause cancer in humans.
Scientists have determined that, over time, NDMA levels increase in ranitidine. These levels also increase more rapidly when ranitidine is stored at higher temperatures. Experts have linked NDMA to several types of cancers affecting the following bodily organs and parts:
In 2019, a company tested a batch of Zantac and detected NDMA in the product. The detection of NDMA in Zantac has led to an FDA warning, widespread product recalls, and thousands of lawsuits.
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In September 2019, online pharmacy Valisure notified the U.S. Food and Drug Administration (FDA) that it detected NDMA in some Zantac batches. That same month, the FDA issued a statement “alerting patients and health care professionals of NDMA found in samples of ranitidine.” The FDA announced that it was studying whether low levels of NDMA pose a risk to consumers. In April 2020, the FDA issued a press release requesting manufacturers to “withdraw all prescription and over-the-counter (OTC) [Zantac] from the market immediately.”
After the FDA issued its statement, numerous companies issued voluntary recalls of over-the-counter ranitidine medicines. Walgreens, Walmart, CVS, and Rite Aid pulled Zantac (both over-the-counter and prescription) off the shelves. Fourteen generic manufacturers and Zantac’s brand-name manufacturer Sanofi-Aventis recalled Zantac in the United States.
Zantac consumers who developed cancer filed thousands of lawsuits against manufacturers of Zantac and other ranitidine medications. Manufacturers named in lawsuits include Pfizer, Sanofi-Aventis, and Boehringer Ingelheim, with claimants alleging Zantac or ranitidine caused their cancer. The lawsuits assert that the manufacturers knew that ranitidine contains a known carcinogen but failed to warn consumers. Consumers have also sued generic manufacturers and retail stores that sold the heartburn medicines.
The many lawsuits have been consolidated in multidistrict litigation (MDL) currently pending in the Southern District of Florida.
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