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The FDA announced on September 13, 2019, that low levels of a probable human carcinogen called N-nitrosodimethlylamine (NDMA), are found in Zantac (ranitidine). Then, on January 8, 2020, the FDA alerted patients and health care professionals of two voluntary recalls of the drug known by the name of Zantac (ranitidine) due to unacceptable levels of NDMA.
The company Sanofi-Aventis is already facing multiple lawsuits alleging the company never warned consumers of the potential risk of cancer according to Legal News Line. Scientific analysis of Zantac and other drugs based on ranitidine have reached a conclusion by the FDA that companies should recall their ranitidine drugs if testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine).
Patients who are currently taking Zantac or other ranitidine based drugs in prescription or over the counter form should consider cessation of taking the medications. Experts recommend if you are a patient that you call your health care professional to discuss your risk and to discuss other treatment options. There are several different treatment options currently on the market that are suitable for many of the same conditions that are now being treated with ranitidine.
Zantac was first introduced to the public in 1983 as part of a new class of medication called H2-receptor antagonists or H2 blockers. H2 blockers are part of a group of medications that reduce the amount of acid produced by the cell lining in the stomach. They are sold as a variety of medications including cimetidine, famotidine, nizatidine and ranitidine under various brand names.
Zantac was marketed as a safe treatment available either over the counter or by prescription to treat acid indigestion, heartburn, sour stomach, GERD and other similar conditions.
NDMA is a chemical compound considered a probable human carcinogen. NDMA is potentially linked to stomach, liver, bladder, small intestine, esophagus, prostate, pancreas cancers, leukemia, Non-Hodgkins Lymphoma, Multiple Myeloma, and kidney cancers.
While the FDA has not issued a mandatory recall as of this time, the recent issuance of a voluntary recall is troubling, especially being the drug is still being investigated. Appco Pharma LLC and Northwind Pharmaceuticals have already taken their ranitidine based drugs off of the market. Sandoz and Apotex have also recalled their generic ranitidine based drug off of all of their USA markets. In addition, major drugstores such as CVS, Walgreens, Walmart and others have already removed their generic versions of ranitidine and Zantac off of their shelves according to CNN.
The FDA is currently working with multiple agencies to review the medications to determine the risk it may pose to users. The FDA has also published their results online and have encouraged other companies using the drug to conduct their own laboratory testing.
Patients who are currently taking Zantac or other ranitidine based drugs in prescription or over the counter form should consider cessation of taking the medications. It is recommended if you are a patient that you call your health care professional to discuss your risk and to discuss other treatment options. There are several different treatment options currently on the market that are suitable for many of the same conditions you are now treating.
Eric Ridenour’s journalism experience began in the 1990s. He was a contributing writer to various publications, investigating government waste and fraud while studying journalism at Citrus College in California. In 2002, he joined the staff of University Wire, or UWire, in Carlsbad, California, where he was an editor until 2010.