Valisure's Testing Methods May Be Flawed And The Cause Of The Spike in NDMA

Sanofi scientists think Valisure's ranitidine tests themselves may be the cause of increases in N-nitrosodimethylamine (NDMA) linked to cancer

Monday, August 3, 2020 - Plaintiffs suing Sanofi for allegedly causing cancer, and the attorneys representing them want to know if science supports the Food and Drug Administration's assertion that the medicine may be responsible for causing stomach, bladder, intestinal, and many other forms of cancer. Valisure Inc., an online drug testing pharmacy, first discovered elevated levels of the carcinogen NDMA in ranitidine tablets sold under a variety of brand names. Before being recalled, Zantac was the world's best-selling brand of ranitidine heartburn and acid reflux medication servicing around 15 million Americans per year and earning Sanofi, the drug's manufacturer, billions of dollars per year in profits. Today, thousands of individuals and the number is growing every day, have hired Zantac Cancer lawyers to file individual claims against Sanofi for failing to warn consumers of what they knew or had an obligation to know about ranitidine's carcinogenic potential. The FDA and others are conducting test but there has been no confirmation to date of Valisure's NDMA findings even though the government health agency issued a recall of Zantac several months ago. The degree to which human health could be affected should the Zantac cancer allegations prove true is illustrated by the U.S. Department of Justice launching investigations of Sanofi and GlaxoSmithKline LLC are over Zantac cancer allegations.

According to Scientific American.com, the company alerted the FDA of its findings immediately and highlighted the degree to which the company was concerned. Valisure alleged it had found: "extremely high levels of [NDMA]... in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine. The petition states that Valisure detected levels greater than three million nanograms per tablet-far exceeding the FDA's permissible daily intake of 96 nanograms." Cancer-causing levels of NDMA are suspected to develop when Zantac is exposed to high temperatures or when it interacts with nitrates in the human stomach. Rather than be distressed about the findings one may deduce that because every single batch tested positive for elevates levels of NDMA, the universal increases may be due to the way ranitidine was tested, and the testing methodology may be flawed. Zantac stomach cancer attorneys can help by offering a free consultation with no obligation to file a lawsuit claim.

In Sanofi's defense, there may be problems with Valisure's testing methods which could have caused the increases in NDMA. According to Scientific American, Valisure heats test samples to extreme, artificial temperature and unrealistic, artificial conditions within the human body. Sanofi spokesperson Nicolas Kressmann told SA in an email: "Valisure only showed detectable NDMA after exposing ranitidine to extreme artificial conditions-when they heated ranitidine to 266 degrees Fahrenheit [130 degrees Celsius...or when they added artificial nitrite far beyond what is ordinarily seen in humans." The FDA has described Valisure's test as a potential reason for the NDMA to increase. "That method is not suitable for testing ranitidine because heating the sample generates NDMA," the FDA said in its Oct. 2 statement."

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• Zantac Bellwether Trials May Focus On Ranitidine Testing Methods That Could Cause NDMA To Accelerate | 3/1/2022
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Lawyers for Zantac Heartburn Medicine Lawsuits

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