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Two new studies by the independent pharmacy Valisure appear to confirm the serious health risks inherent with Zantac, establishing how easily the active ingredient ranitidine converts to cancer-causing chemicals under simulated gastric conditions the pill would experience as it passes through the body.
Zantac and other generic ranitidine drugs have been used by millions of Americans for years to prevent and relieve heartburn. However, the FDA recalled Zantac from the market last year, after finding high levels of the known carcinogen NDMA (N-nitrosodimethylamine) that developed as the pills were stored under certain conditions. However, these new findings suggest that the development of NDMA is an inherent Zantac risk, exposing users to the cancer-causing chemical that appears to be released inside the human body.
Valisure first rang the warning bell about the potential Zantac cancer risks in September 2019, after independent testing of pills in their inventory found dangerous levels of NDMA across all ranitidine-based medications.
The pharmacy began testing pills after a series of valsartan recalls, where multiple versions of the blood pressure drug became contaminated with NDMA due to changes in the generic drug making process. However, the Zantac risks were not caused by a manufacturing problem, but rather appears to be a result of the inherent instability of ranitidine when exposed to high temperatures or certain conditions, which could occur during storage, transport or inside the body.
In new findings published in JAMA Network Open and MedRxiv on January 29, Valisure researchers highlight just how easy it is for Zantac to transform into NDMA, under a variety of situations as the medication is used.
In a research letter published by JAMA Network Open, Valisure looked at conditions which stimulated ranitidine NDMA production by imitating gastric processes, which occur in the stomach and digestive system. After two hours in conditions similar to that of the stomach, a 150 mg tablet of cool mint Zantac converted into 947 nanograms (ng) of NDMA, which is 10 times higher than the FDA’s daily acceptable limit of 96 ng of NDMA consumption. Most users took two Zantac at a time. However, Valisure researchers also found that when nitrate concentrations were increased, the same Zantac tablet unleashed a flood of 320,000 ng.
“The data published today strongly supports decades of research that ranitidine is fundamentally unstable, can form NDMA in a variety of conditions including in the human body, and could be carcinogenic and toxic to humans,” David Light, Founder and CEO of Valisure, and one of the lead study authors, said in a January 29 press release. “These findings underscore the vital importance of additional quality assurance testing of on-market drug products.”
The MedRxiv study looked at data on more than 10,000 cancer patients and found an association between users of Zantac and an increased risk of breast cancer, thyroid cancer, bladder cancer and prostate cancer, when compared to users of other heartburn drugs that did not contain ranitidine.
Zantac Cancer Lawsuits
The findings come as a growing number of former users are now pursuing Zantac lawsuits against makers of various ranitidine-containing drugs, indicating that years of exposure to NDMA in the pills caused the development of breast cancer, kidney cancer, stomach cancer, testicular cancer and other injuries as the chemical passed through their body.
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.
There are currently hundreds of 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 lawyers continue to review claims for individuals nationwide.
It is expected the litigation may become one of the largest active mass tort proceedings involving a pharmaceutical medication before the first cases reach trial.