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Standardized Nitrosamines Testing Methods Will Determine The Outcome of Zantac Cancer Trials

The FDA says that testing for NDMA should be

Wednesday, November 10, 2021 - The director of the FDA's Office of Testing and Research in St. Louis, Missouri thinks that the agency must establish the best way for all companies to test their drugs for the presence of the carcinogen NDMA. "Pharmaceutical manufacturers should ensure that the analytical tests they are using are "fit for purpose" to ensure that the right test is measuring the right impurity in testing their drugs for nitrosamines, Jason Rodrigues told Most people have heard by now that Zantac ranitidine, once the leading brand of heartburn and acid reflux medicine, has been taken off of the market due to a cancer scare. Zantac ranitidine is thought to become NDMA a highly carcinogenic substance when exposed to high temperatures such as those in storing and transporting the drug, and also the higher temperatures within the stomach. Thousands of individuals with cancer have filed Zantac cancer lawsuits after taking the medicine regularly for more than one year and allegedly contracting cancer of the stomach, bladder, esophagus, colon, prostate, and breast. A pool of around 400 of the strongest Zantac cancer cases has been organized into multi-district litigation (MDL) to avoid repeating administrative court proceedings over and over. The MDL judge will also study the testimony given during pre-trial MDL hearings The heartburn medicine cancer scare affect more than 15 million Americans that were taking the heartburn medicine at the time of its FDA recall in 2020. Legal experts think that if the science presented by Valisure holds up, Zantac cancer could become the largest mass tort litigation of all time.

Online prescription drug testing pharmacy Valisure first found elevated levels of NDMA several years ago when one of the company's founders tested the drug before giving it to his daughter. According to CEO David Light, "Valisure routinely tests for the presence of various carcinogens, including NDMA, in all our medications and it was through this routine analysis that Valisure identified ranitidine's inherent instability and propensity to form high amounts of the probable human carcinogen NDMA." Subsequent tests found the carcinogen in every Zantac sample they tested. Valisure found up to 3 million nanograms per Zantac tablet, far exceeding the 96 nanograms per tablet limit set by the FDA. While Valisure is certain that ranitidine is an unstable molecule and responsible for the elevated NDMA, the FDA's tests are not so sure. The FDA told each company that manufactured ranitidine to test it for the presence of NDMA and to remove them from the market if they exceeded the 96 nanogram limit. FDA tests found levels of NDMA that exceeded the 96 nanograms only slightly. "FDA has determined that the levels of NDMA in ranitidine and nizatidine are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats." Valisure used the same testing method as that used and recommended by the FDA. Some think that the company may have overheated their testing samples and that could be the reason for the elevation in NDMA.

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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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