Their Will Be A Battle Concerning The Way Valisure Tested Zantac Ranitidine For NDMA
Valisure will have to prove that modifying the FDA's testing procedures did not affect NDMA levels
Thursday, January 27, 2022 - Sanofi and Glaxo Smith Kline, the two defendants in thousands of heartburn medicine cancer lawsuits, are requesting full disclosure of all of the evidence that their primary accusers allegedly have on them. The makers of Zantac think that the method in which Valisure tested Zantac ranitidine may have caused the heartburn and acid reflux medicine to degrade into N-nitrosodimethylamine (NDMA), a deadly carcinogenic molecule. There is no question that NDMA is carcinogenic, so much so that it has been banned in the US. Research scientists would give it to laboratory test animals to induce cancer tumors to study. NDMA is also a by-product of the industrial manufacturing process and pollutes the air, water, and soil worldwide. NDMA is in the food we eat from the soil but in smaller, non-carcinogenic quantities. The US Food and Drug Administration has established a limit of 96 nanograms per tablet as an acceptable level of NDMA for daily Zantac users to ingest safely. Foods like hot dogs and processed meats contain much higher amounts of NDMA that are not eaten as often, therefore, the acceptable NDMA level is set higher. Valisure has said that they used the same testing methods as the FDA, only that they modified it to be more sensitive.
The accuracy of Valisure's ranitidine testing method is the center of Sanofi's discovery efforts. LabManager.com investigated Valisure's methodology and found that the FDA has a problem with Valisure's ranitidine testing. An article on the subject titled " Ranitidine (Zantac) Recall Brings into Question Accuracy of Safety Testing Methods," alleges, "The company that detected impurities in ranitidine drugs (Valisure) says FDA testing methodology is insufficient, while FDA counters that the company's testing method was inaccurate." The FDA has been non-committal about their testing and findings of NDMA in ranitidine after receiving a citizen's petition from Valisure chairman David Light, demanding all ranitidine be recalled. The FDA found levels of NDMA only slightly higher than their 96 nanograms per tablet guideline and labeled the overage as insignificant. Valisure's position on ranitidine is that it is an inherently unstable molecule and can degrade into NDMA when heated or when it comes into contact with chemicals in the stomach. The FDA disagrees with this single-bullet theory and says they have studied ranitidine in-depth over the last three years and discovered much on the subject. Jason Rodriguez, director of the division of complex drug analysis at the US Food and Drug Administration's (FDA's) Office of Testing and Research in St. Louis. told the Regulatory Affairs Professional Society last fall, "Nitrosamine impurities can be introduced in three ways, with contamination occurring during the manufacturing process or via the supply chain; impurities may also develop because of problems with the drug's stability." Thousands of Zantac cancer lawsuits have been filed against Sanofi and Glaxo assuming that Valisure's NDMA testing methods were correct.
More Recent Heartburn MedicineLawsuit News:
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Lawyers for Zantac Heartburn Medicine Lawsuits
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.