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Zantac Bellwether Trials May Focus On Ranitidine Testing Methods That Could Cause NDMA To Accelerate

One side thinks that ranitidine is unstable and breaks down to become carcinogenic naturally

Tuesday, March 1, 2022 - More than 1800 Zantac heartburn medicine cancer lawsuits have been organized into multidistrict litigation (MDL) in which individuals assert they have developed cancer from taking Zantac. Several of these cases will serve as bellwether trials that will start in mid-2023, to see how juries react to the evidence that will be provided by both sides. The US Food and Drug Administration (FDA) ranitidine test results could play a central role in Zantac cancer lawsuits. Individuals that have used the medicine regularly for more than a year have reported developing different types of cancer and accused ranitidine as being the source.

Independent, third-party drug testing pharmacy Valisure tested Zantac and found highly elevated levels of NDMA a carcinogenic found in nature and one used by cancer researchers to induce tumors in lab animals to be studied. The fledgling internet startup company has received international publicity after sending a citizen's petition to the FDA demanding that the agency recall all forms of ranitidine. In 2019, the FDA tested ranitidine and failed to find the highly elevated levels of NDMA and that there was no reason to panic. "Through our testing so far, we have found levels of NDMA in ranitidine that are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats. We also conducted tests that simulate what happens to ranitidine after it has been exposed to acid in the stomach with a normal diet and results of these tests indicate that NDMA is not formed through this process," the FDA told consumers in November 2019. The FDA recommended that ranitidine manufacturers test ranitidine themselves and voluntarily withdraw their product from the market if the results are higher than the 96 nanograms per day threshold that the FDA considers safe.

The FDA stressed that companies adhere to the FDA's exact testing procedures and not overheat the product as Valisure is suspected of doing. Scientists think that overheating ranitidine test samples could cause NDMA levels to accelerate. "The lab used the same testing method as Valisure had, using gas chromatography/mass spectrometry (GC/MS) to gauge nitrosamine impurity levels in samples," according to RAPA. Questions were raised when FDA inspectors took a look at what was left of the Valisure ranitidine test samples. Pharmacy Times recently told readers, "The FDA recommends using an LC-HRMS testing protocol to test samples of ranitidine since this method does not use elevated temperatures. LC-HRMS testing has also shown the presence of much lower levels of NDMA in ranitidine medicines than reported by the third-party laboratory." One FDA regulator looked at Valisure's ranitidine sample that they tested and stated the obvious "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 RAPA, "After testing the samples, FDA staff discovered black material in the sample headspace that proved to be the "charred remains" of the tested tablets. This was not something that we usually see for headspace, so we began to think, 'What is going on here?" said Rodriguez. "Is ranitidine undergoing some thermal degradations to form 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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