Ranitidine Tests May Have Produced Thermal Degradation Causing The Spike In NDMA

Plaintiffs that think that Zantac ranitidine naturally degrades to become carcinogenic may have an uphill battle

Tuesday, November 16, 2021 - Nitrosamines contamination testing will continue to be the focus of the analysis of Zantac heartburn and acid reflux cancer trials as we move into 2022 and beyond. The types of testing methods that the FDA and drug manufacturers use will be on trial during the Daubert hearings in 2022. The objective will be to determine whether or not the molecules that comprise ranitidine are unstable and naturally degenerate into N-nitrosodimethylamine (NDMA), or if the company that tests the drug overheated it and caused the NDMA spike themselves, which would be quite embarrassing for them, to say the least. Thousands of former Zantac users have filed Zantac cancer lawsuits thinking that taking ranitidine caused their cancer. Startup online testing pharmacy Valisure claims to have tested ranitidine and found it to contain alarmingly high levels of NDMA and then reported their results to the FDA. Implementing standardized NDMA testing methods is critical to ensure that the results that one lab finds can be cross-checked by multiple other independent testing facilities. An article published recently by the Regulatory Affairs Professional Society (RAPS) sums up the dilemma that the judge presiding over multidistrict litigation in the Zantac litigation may face when deciding what science holds water. "Pharmaceutical manufacturers should ensure that the analytical tests they are using are fit for purpose to ensure that the right test is measuring the right impurity in testing their drugs for nitrosamines, says Jason Rodriguez, director of the division of complex drug analysis at the US Food and Drug Administration's (FDA's) Office of Testing and Research in St. Louis. Manufacturers should also use orthogonal, or additional methods, to double-check results," according to RAPS.

Mr. Rodriguez's testimony will be sought during scientific hearings on heartburn medicine cancer in multidistrict litigation. His thoughts on NDMA formation are at odds with those of Valisure CEO David Light who contends that his tests prove that ranitidine is an "inherently unstable" molecule and naturally degrades into carcinogenic NDMA. According to RAPS, Mr. Rodriguez identified Valisure as the company that filed the citizen's petition with the FDA recommending the ranitidine recall in 2020. He then made an alarming discovery after using the same testing method as Valisure. "FDA subsequently tested the samples to see if their findings correlated with the lab's results. The agency "bought whatever acidic blockers we could find, and we ran the method in our lab," said Rodriguez. The lab used the same testing method as Valisure had, using gas chromatography/mass spectrometry (GC/MS) to gauge nitrosamine impurity levels in samples. We saw that the levels (NDMA) while present are still much lower and not nearly at the level of those that were cited by a private lab," said Rodriguez." After testing Rodriguez was alarmed to find that Valisure's testing method so overheated the testing sample that there was little left of it. "After testing the samples, FDA staff discovered black material in the sample head space that proved to be the "charred remains" of the tested tablets. "This was not something that we usually see for head space, so we began to think, 'What is going on here?'" said Rodriguez. "Is ranitidine undergoing some thermal degradations to form NDMA?"

More Recent Heartburn MedicineLawsuit News:

• Zantac Cancer Trials Are In Discovery To Begin In October 2022 | 7/19/2022
• Zantac Cancer Lawsuits Could Hinge On The Validity of Ranitidine Testing Methods | 7/11/2022
• Zantac Cancer Bellwether Trials In California Could Set The Stage For A Global Settlement Offer | 7/5/2022
• The FDA Recommended Protein Pump Inhibitor Drugs Like Prilosec And Nexium That May Damage Health More Than Zantac | 6/23/2022
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Lawyers for Zantac Heartburn Medicine Lawsuits

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.