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Zantac Testing Accusations Heat Up With FDA Investigation Of Online Prescription Drug Testing Lab

The FDA wants to know why Valisure is finding so many products like sunscreen and hand sanitizers test positive for carcinogens when they escaped detection by the government health watchdog agency

Monday, April 25, 2022 - The US Food and Drug Administration (FDA) continues to challenge online prescription drug testing laboratory Valisure when the latter makes allegations that they have found potentially carcinogenic compounds in health products consumers use every day. Valisure hails itself as being an independent prescription drug testing lab without bias however its claims sometimes fly in the face of those at the FDA. In the most impactful instance, Valisure tested Zantac, the world's leading heartburn and acid reflux medicine, and found it contained levels of carcinogenic N-nitrosodimethylamine (NDMA) "orders of magnitude" higher than the 96 nanograms per day the FDA deems acceptable. The tests led to a ranitidine recall by companies the FDA ordered to test the medicine regularly. Valisure claims that heating ranitidine causes it to become unstable and degrade into NDMA proven to be a cancer-causing molecule. Thousands of people that suffer from heartburn medicine cancer of the stomach, bladder, esophagus, colon, prostate, and others have filed Zantac lawsuits. On April 1, 2020, the FDA ordered a recall of all forms of ranitidine but failed to confirm the magnitude of Valisure's findings saying that their tests of ranitidine found levels only slightly above what is acceptable. Valisure was accused of exaggerating their claims of Zantac ranitidine levels being in the millions of NGS by Sanofi, the maker of Zantac, but the judge in the matter denied Sanofi from pursuing discovery on the topic. When Valisure last year tested hand sanitizer and found benzene, a known carcinogen, the FDA initiated a months-long investigation of Valisure to see if they were overstepping its ability and exaggerating its findings. Sanofi is suspected of challenging the credibility of Valisure being just a fledgling company looking for media attention.

The FDA's Valisure drug testing investigation was reported on the other day in Consumer Reports magazine and concluded that Valisure's testimony about ranitidine and other product carcinogens could be in doubt. CR reports, "The agency inspected Valisure after its damning findings led to major recalls. Now, consumer claims of harm against implicated companies could be derailed." One side of the coin says that the more products Valisure finds are carcinogenic and have slipped through the cracks at the FDA, the worse Valisure makes the government look. Valisure suspects that could be the motive for the FDA investigating Valisure when they should be spending taxpayer money and their time digging more deeply into the safety of drug and health care products. Such are the thoughts of Connecticut lawmaker Rosa DeLauro, from the state where Valisure is headquartered. "Valisure's work has raised the alarm on both the quality and safety of drugs and personal care products for millions of consumers and their families. Instead of this ongoing hostility, FDA should embrace their efforts in the pursuit of safeguarding the public's health." Ms. DeLaura wrote in CR.

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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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