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Unlike recent recalls involving valsartan, metformin and other medications which became contaminated with the carcinogen N-Nitrosodimethylamine (NDMA) during the drug manufacturing process, lawsuits allege the cancer side effects from Zantac appear to be an inherent byproduct of the active pharmaceutical ingredient in the recalled heartburn drug, ranitidine.
Zantac (ranitidine) was one of the most widely known brand-name medications in the world before all versions were removed from the market, after it was discovered late last year that nearly all pills contained dangerous levels of NDMA that may increase the risk of cancer.
The problems were first identified by researchers at the independent pharmacy Valisure, which began testing all medications for NDMA after the chemical resulted in widespread recalls for valsartan, irbesartan, losartan and other widely used generic blood pressure drugs. However, unlike those recalls, where NDMA was created as a byproduct of changes in the generic drug making process, Valisure determined that Zantac problems involved the active ingredient ranitidine converting to NDMA over time when introduced to high heat during storage, or even as it is digested inside the human body.
In January 2020, a report published by another independent laboratory, Emery Pharma, found that levels of NDMA rose in Zantac following several days of exposure to high heat. At temperatures of just 77 degrees Fahrenheit, the pills generated 25 ng of NDMA over a period of 12 days, which the pharmacy said could be comparable to the pills being left in a hot car or are otherwise stored in a warm location for a few days.
This suggests there is no way to prevent NDMA through manufacturing changes, since it appears to be a natural chemical byproduct of ranitidine, Zantac’s active ingredient. This also suggests Zantac cancer problems have been there since it first hit the market, and that millions of users worldwide have been exposed to high levels of cancer-causing agents through the use of this popular drug.
A growing number of former users are now pursuing ranitidine lawsuits against makers of various versions of Zantac, indicating they developed breast cancer, kidney cancer, stomach cancer, esophageal cancer, testicular cancer and other injuries caused by NDMA as it passed through their body.
“Zantac and its generic forms inherently harbor a well-known cancer-causing compound, N-Nitrosodimethylamine (NDMA),” according to a master complaint (PDF) filed in a consolidated litigation pending in the federal court system. “For decades, Defendants sold ranitidine-containing products, reaping substantial profits. Now, Plaintiffs across the country seek to hold Defendants accountable for causing hundreds of thousands of people to develop cancer.”
The lawsuits allege drug makers knew about these inherent risks with ranitidine in Zantac, but withheld information from consumers, doctors and regulators for decades
Given common questions of fact and law raised in complaints filed in U.S. District Courts nationwide, a federal multidistrict litigation (MDL) was established earlier this year, centralizing all claims pending throughout the federal court system before U.S. District Judge Robin L. Rosenberg is presiding over the coordinated discovery and pretrial proceedings.
“Ranitidine-containing products generate NDMA as the ranitidine molecule (1) breaks down in the human digestive system; (2) interacts with various enzymes in the human body; (3) reacts over time under normal storage conditions and which increases significantly when exposed to heat; and/or (4) during the manufacturing process,” according to allegations raised in the Master Complaint filed by plaintiffs in the MDL. “In aggregate, ranitidine-containing products were akin to billions of Trojan horses that smuggled dangerously high levels of NDMA into the bodies of millions of consumers.”
There are currently at least 548 lawsuits included in the litigation, with tens of thousands of additional cases registered on a census established by the court to allow the parties to gauge the size an scope of the litigation as Zantac recall lawyers continue to review claims for individuals nationwide.
It is expected that Zantac litigation may become one of the largest active mass tort proceedings involving a pharmaceutical medication before the first cases reach trial.