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The FDA's Recent Take On NDMA Sheds Light On Zantac Cancer Lawsuits

The Food and Drug Administration (FDA) is grappling with scientists finding carcinogens in many types of drug tablets

Wednesday, September 29, 2021 - The science underlying the ranitidine molecule will take center stage when the Zantac scientific hearings begin early next year. Zantac ranitidine is considered inherently unstable and may degrade into N-nitrosodimethylamine (NDMA) under the stress of high heat. NDMA is a proven carcinogenic. Online prescription drug testing pharmacy Valisure found highly elevated levels in Zantac made from ranitidine. NDMA is waste from industrial manufacturing, and scientists use NDMA to induce tumors in laboratory animal testing. 85% of the US drug manufacturing process occurs overseas in China and India where some of the NDMA contamination is likely to have occurred. Zantac cancer lawsuits against Sanofi, the maker of the leading heartburn and acid reflux medicine, allege that taking it regularly for prolonged periods has caused them to develop stomach, bladder, and other forms of cancer. FDA testing of Zantac ranitidine did not confirm the highly elevated levels of NDMA. The agency decided to recall all forms of ranitidine out of an abundance of caution until testing was complete. Valisure seems convinced that ranitidine itself produces dangerously high levels of NDMA and has found Zantac to contain more than 3 million monograms of NDMA in one tablet. The FDA has established that 96 nanograms per tablet to be safe. It could be that Valisure's testing methods overheated the testing samples and were to blame. Valisure scientists modified the FDA's testing methods which could have caused the spike in the carcinogen. Zantac ranitidine is by no means the only drug that has tested positive for high levels of NDMA. Pfizer, the other day, recalled all lots of its best-selling smoking cessation drug Chantix due to finding elevated levels of NDMA. Higher than acceptable levels of NDMA were in blood pressure and diabetes medicines.

The FDA has offered level-headed advice to consumers to keep everyone calm. The agency understands that people take certain drugs to treat serious health issues. Concerning the Zantac ranitidine recall, the agency knows that heartburn pain could be an indication of gastrointestinal reflux disease (GERD). If GERD is untreated it could develop into esophageal cancer. One should seek the advice of their doctor and perhaps switch to a PPI drug like Pepcid, rather than give up antacids. Sanofi offers a new form of Zantac called Zantac 360 made from famotidine that may be safer. Concerning the latest Chantix NDMA cancer recall, the agency advised consumers of the following. "The health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline, and taking nitrosamines at or below acceptable levels does not increase the risk of cancer. The chemical may increase the risk of cancer if someone is exposed to high levels over long periods lower levels of nitrosamines are common in many foods, including grilled and cured meats, some vegetables, and dairy products, and are thought to not cause problems," reported.

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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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