For decades, Zantac (ranitidine) was one of the most popular antacid drugs on the market. Many Americans took Zantac thinking it was a safe and effective solution for heartburn and a host of other digestive issues. But then, the U.S. Food and Drug Administration (FDA) found that it contained dangerously high levels of a known carcinogen called N-Nitrosodimethylamine (NDMA). This discovery resulted in a nationwide market withdrawal of all prescription, over-the-counter (OTC), and generic brands of Zantac in 2020.
What Is NDMA?
The FDA, the Environmental Protection Agency (EPA), and the World Health Organization (WHO) all recognize NDMA as a carcinogen. The FDA’s acceptable daily intake of NDMA is set at a very low 96 nanograms (ng), equivalent to 96 billionths of a gram.
Zantac Linked to Numerous Cancers
Studies have shown that the NDMA in Zantac may increase the risk of developing the following cancers:
● Bladder cancer
● Breast cancer
● Esophageal cancer
● Kidney cancer/renal cancer
● Lung cancer
● Prostate cancer
● Stomach/gastric cancer
● Pancreatic cancer
● Liver cancer
● Thyroid Cancer
The latest of these studies, “Analysis of Ranitidine-Associated N-Nitrosodimethylamine Production Under Simulated Physiologic Conditions” by Valisure, is perhaps the most concerning. Researchers investigated how the human stomach digests Zantac tablets, testing a broad range of pH, ranitidine, and nitrite concentrations. The results showed that Zantac “may be a significant source of NDMA” when undergoing a range of “physiologically relevant conditions.” For example, NDMA levels in Zantac surpassed established limits by 300% during digestion.
Although Valisure researchers concluded the study with a call for further investigation, these findings remain troubling. The FDA market withdrawal in 2020 noted that NDMA levels increased when the drug was stored at higher than room temperatures; it did not state that the ranitidine molecule itself creates dangerously high levels of NDMA. The Valisure study, on the other hand, did note that the “ranitidine molecule itself” is a “significant source of NDMA.”
In another study, published in Cancers, researchers delved into data from the FDA's Adverse Events Reporting System (FAERS) to study reports of cancers from drugs within the same class as ranitidine: histamine H2-receptor antagonists, or H2 blockers. They found an elevated link between these drugs and numerous cancers, including liver/bile duct cancer and pancreatic cancer.
“One of the things we have said from the very beginning is this litigation is not about a contaminated drug – this drug is defective and dangerous by design,” said R. Brent Wisner, top-rated attorney and vice president of Baum Hedlund Aristei & Goldman. “The latest studies confirm that when Zantac is used as intended, the molecule itself produces astoundingly high levels of NDMA and significantly increases the risk of developing cancer.”
If you have developed cancer after taking Zantac, you may qualify for compensation. At Baum Hedlund Aristei & Goldman, we hold drug manufacturers accountable for putting profit over consumer safety.