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Nitrosamines NDMA Levels in Zantac Found To Be Thousands of Time Higher Than Acceptable

Zantac users may have traded heartburn and acid reflux discomfort for cancer, a far more deadly disease

Tuesday, June 30, 2020 - Online drug testing pharmacy Valisure found levels of nitrosamines (NDMA), a known carcinogen, 3000 times higher than the FDA's daily allowable intake limit of 96 nanograms in Zantac, the world's best-selling heartburn medication. According to MedPage Today, Valisure's CEO David White tole a Congressional Committee, "While a "body-temperature" model used in Valisure's ranitidine testing didn't turn up NDMA, another test mimicking the stomach environment yielded 300,000 ng of NDMA from a 150-mg tablet. That's more than 3,000 times the level the FDA set when it had to decide how much NDMA was tolerable in angiotensin receptor blockers (ARBs)." MedPage also reported other researchers with similarly shocking findings of the potential for Zantac and other heartburn medications to cause cancer. "William Mitch, Ph.D., of Stanford University, co-authored a 2016 paper that found an average of 48,000 nanograms of NDMA in 24-hour urinary excretion after participants took a 150-mg ranitidine dose, a 400-fold spike from baseline." CEO Light told the committee that ranitidine was unstable and can break down given high storage temperatures such as those found in a locked car left in the afternoon sun.

The unacceptable NDMA levels in blood pressure, heartburn, and diabetes drugs have led to recalls and concern that the nation's medical supply chain may be in jeopardy. Valisure initially found elevated levels of nitrosamines in angiotensin II receptor blockers (ARBs) taken to reduce blood pressure and prevent heart failure. After that, the company's investigation expanded to include heartburn medicines, ranitidine, and nizatidine, sold under the brand name Zantac and others, followed by metformin, a diabetes medication that is prescribed to diabetics with type 2 diabetes to control blood sugar levels. According to the Food and Drug Administration, "The U.S. Food and Drug Administration has been investigating the presence of genotoxic impurities, called nitrosamines, in some types of drugs. Over the past year and a half, several drug products including angiotensin II receptor blockers (ARBs) and ranitidine, commonly known as Zantac, have been found to contain small amounts of nitrosamines such as N-Nitrosodimethylamine (NDMA). During this time, there has been an ongoing investigation into the presence of nitrosamines in other drug products. This effort is focused on ensuring the drugs used by Americans continue to meet strict quality standards."

When the news of the elevated levels of impurities was initially revealed, Sanofi, the maker of Zantac, the world's best-selling heartburn and acid reflux medication, did the right thing and voluntarily removed the product from store shelves and discontinued North American sales. The FDA ordered a recall of most that and most other heartburn medication shortly thereafter. Hundreds of individuals with cancer of the stomach, bladder, esophagus, prostate, breast, pancreas, and many other forms of cancer blame Zantac for causing their disease and have hired Zantac Cancer Attorneys to file lawsuits claiming that the heartburn medication caused their fatal disease. If you or a loved one have taken Zantac regularly for many years and have cancer or have a loved one who has done so, you may qualify to file a claim against Sanofi, the maker of Zantac heartburn and acid-reflux medicine.

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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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