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FDA Asked Companies To Test Their Ranitidine Products And Voluntarily Withdraw Them If NDMA Levels Were Too High

If one looks more carefully at the April 2020 FDA recall of ranitidine, one might conclude that it was not a typical recall

Thursday, January 6, 2022 - The FDA told manufacturers of products that contained ranitidine that they were advised to test their products for the presence of NDMA above 96 nanograms per capsule and recall those that exceeded that level. The FDA wrote, "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." In addition to the FDA's lack of urgency regarding ranitidine, there is growing evidence to support the fact that the NDMA level in Zantac ranitidine was within the FDA's acceptable limit of 96 nanograms per capsule when the drug was manufactured and left for retail shelves. The recently published a piece by a pharmacist who has written extensively about the formation of NDMA in certain types of blood pressure, heartburn, diabetes, and smoking cessation drugs. The author cites credible studies that indicate that the NDMA contamination of Zantac heartburn and acid reflux medicine may have occurred after it left Sanofi's hands at the factory. "In one study, investigators found that ranitidine contained only 18 nanograms of NDMA after it was manufactured. However, when stored at 158 degrees Fahrenheit (70 degrees Celcius) for 12 days -- as if the drug had been left in a hot car -- NDMA dosages rose above 140 ng. This is only slightly above the 96 ng limit the FDA has deemed safe, but this was after just 12 days." This is cause for concern because of the short time after manufacturer NDMA levels started to accelerate and it is assumed the acceleration would continue over time. "This suggests that some medications can leave the factory with a safe amount of NDMA but if kept for too long at home or on the store shelf can exceed known acceptable limits by the time patients use them."

These studies support the FDA's ranitidine tests that concluded that the levels of NDMA were only slightly higher and that the recall was due to the government's inability to regulate the temperatures that the drug was being transported and stored. The FDA also was not inclined to establish an expiration period after which the drug was not safe. What was most distressing, however, were the tests that simulated gastric stomach conditions produced tens of thousands of nanograms of NDMA, levels that are certainly a heartburn medicine cancer concern. Thousands of people have filed Zantac cancer lawsuits accusing Sanofi of failing to warn them of what they knew about NDMA accelerating when heated, or what they were obligated to know. One study published in 2016 found tens of thousands of nanograms in the urine of people who took Zantac ranitidine, but the results were later retracted because the high NDMA levels could have been created during testing and not in the body or before. The FDA explicitly stated that they were recalling ranitidine, not because of the high levels of NDMA, but because they could not regulate or monitor transportation or storage temperatures.

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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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