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The FDA Suspects Zantac Could Contain Five More Cancer-Causing Impurities

In addition to NDMA, N-nitrosodiethylamine, the FDA has found five more compounds in ranitidine that may also cause cancer

Saturday, March 6, 2021 - Online drug testing pharmacy Valisure, the first type of pharmacy to offer to fill prescriptions online after testing the drug for freshness, purity, and contaminates, found highly elevated levels of N-nitrosodiethylamine (NDMA), a known carcinogen and byproduct of most manufacturing processes. In September 2019, Valisure immediately notified the FDA about the cancer scare that heartburn products (ranitidine, commonly known as Zantac, and nizatidine presented, and they took swift action to remove it from store shelves. The first move the FDA made was to recommend that all ranitidine manufacturers including Sanofi, voluntarily recall their ranitidine and nizatidine products. Valisure found levels of NDMA that were thousands of times greater than the 96 NGS per tablet the agency established as the safe threshold. It was initially suspected that storing ranitidine at room temperature caused NDMA to increase over time to unacceptable levels. On April 1, 2020, FDA issued the order that all ranitidine products were to be taken off of the market in the United States.


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In addition to ranitidine, the FDA has identified other similar agents that the World Health Organization considers to be possibly carcinogenic. According to the FDA, "FDA has identified seven nitrosamine impurities that theoretically could be present in drug

products: NDMA, N-nitrosodiethylamine (NDEA), N-nitroso-N-methyl-4-aminobutanoic acid (NMBA), N-nitrosoisopropylethyl amine (NIPEA), N-nitrosodiisopropylamine (NDIPA), Nnitrosodibutylamine (NDBA), and N-nitrosomethylphenylamine (NMPA) (Figure 2). Five of them (NDMA, NDEA, NMBA, NIPEA, and NMPA) have been detected in drug substances or drug products." These chemical compounds are so carcinogenic, they are banned in the US after serving for years as a catalyst to induce cancer tumors in experimental laboratory animals.

Millions of People are just now discovering that a form of heartburn medicine, ranitidine, was recalled in May of 2020, nearly one year ago, and want answers. The US Food and Drug Administration (FDA) has led the way in removing and banning the heartburn medicine Zantac until more tests can determine what went wrong. There has also been misinformation surrounding the FDA's findings, and many people want to know if their heartburn medicine will ever make it back to the market. Thousands of people with cancer of the stomach, bladder, esophagus, intestines, prostate, colon, and many other forms of cancer have filed suit against Smith Kline Glaxo (GSK), and Sanofi, the makers of the drug, for failing to warn consumers that it might contain a deadly cancer-causing compound. Retailers Walmart, Rite Aid, and CVS have also been named as co-defendants in lawsuits. Zantac Cancer Lawyers continue to interview individuals that have used Zantac regularly for many years and now have cancer. You may qualify to file a claim and join other alleged Zantac cancer victims whose cases have been organized at the Federal level in multidistrict litigation. In MDL, the scientific complexities of the chemistry behind Zantac causing cancer can be finalized and certified.

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OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The Onder Law Firm has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.


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