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Researchers Have Long Suspected Ranitidine Was Unstable But Changed Their Minds

High levels of NDMA in Zantac were found long ago but the study has since been mysteriously retracted

Monday, January 3, 2022 - There is no doubt that thousands, maybe hundreds of thousands of people that took Zantac have developed cancer of one sort or another, but the question remains. Is there is a concrete link between the two? Scientists agree that ranitidine, and other forms of drugs, turn into N-nitrosodimethylamine (NDMA) when they are heated to certain temperatures, much like the more carcinogenic red meat becomes the more well-done it is cooked. The answer to that question is at the heart of more than 100,000 Zantac lawsuits seeking to hold Sanofi, the maker of Zantac ranitidine, and other brands like Zantac famotidine, responsible for failing to warn consumers of the heartburn medicine cancer risks. Most plaintiffs claim that had they been warned of the potential carcinogenic nature of ranitidine, they would not have chosen to take Zantac, and instead may have selected another medicine like Pepcid AC, made from famotidine. Sanofi has rebranded Zantac ranitidine as Zantac 360 famotidine, the same as Pepcid. Famotidine is slower to act but much stronger and longer-lasting.

Most people assume that the Zantac ranitidine cancer issue started in 2019 when startup, online prescription drug testing pharmacy Valisure tested ranitidine and found levels orders of magnitude greater than what the FDA presumed were safe. That was not the first time that Zantac ranitidine had come under fire as potentially being unsafe. WebMD reported that the question was being raised back in 2016 when researchers found levels of NDMA in Zantac user's urine, 400 times the acceptable threshold established by the Food and Drug Administration. Upon publication of this information, Sanofi did not attempt to update the Zantac warning label to reflect the cancer connection, prompting the Department of Justice to open a federal investigation of the company for lying about their knowledge of the situation. In the meantime, the authors of the study that found the excessive NDMA in the study subject's urine, retracted the paper siting that the testing methods they used were unreliable and presumably over-heated the samples to levels that were not reproduced during transportation, retail storage of the pills, or recreation of internal stomach temperatures. WebMD reported, "the co-authors of that paper have asked the journal, Carcinogenesis, to retract that paper, and the journal has. In the retraction notice, the journal editors said that ''the authors have informed the journal that their NDMA measurements are not reliable." The problem has to do with the method they used to measure the NDMA levels. They found levels of NDMA as high as 47,600 nanograms -- much higher than the 96 ng the FDA says is an acceptable daily level of NDMA from a drug."

Whether or not Zantac each plaintiff's cancer was caused by taking Zantac is a question that only juries can decide. The Food and Drug Administration (FDA) thinks that Zantac ranitidine is safe when not overheated, a promise the agency can not guarantee. The agency recalled ranitidine in all of its forms including Zantac in April 2020, out of an abundance of caution.

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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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