A pair of new studies appear to confirm the alleged link between cancer and Zantac, a popular heartburn medication known generically as ranitidine.
Both studies were conducted by Valisure, the online pharmacy that first raised the alarm about the drug’s potential link to cancer.
The first study was published on January 29th in the Journal of the American Medical Association (JAMA) Network Open and illustrated how ranitidine might be a significant source of N-Nitrosodimethylamine (NDMA) – a known carcinogen — under a range of physiologically-relevant conditions.
“Specifically, under simulated gastric conditions, NDMA yield from a standard tablet of ranitidine was seen to increase with both rising nitrite and decreasing pH, to levels up to three orders of magnitude beyond established limits of exposure,” Valisure said in a statement announcing the findings.
The second study was published in MedRxiv and involved evaluations of 10,347 cancer patients. The analysis found a significant association between the use of ranitidine and elevated diagnosis rates of breast, thyroid, bladder, and prostate cancers. The study’s chemical analysis also suggested that the rapid formation of NDMA might continue for extended periods of time when ranitidine remains exposed to gastric conditions. This is particularly concerning, as the use of Zantac has been associated with longer gastric emptying times.
“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,” said David Light, Founder & CEO of Valisure and an author on both studies. “These findings underscore the vital importance of additional quality assurance testing of on-market drug products.”
In 2019, Valisure warned that it had detected excessive levels of NDMA in every Zantac sample – including over-the-counter and generic versions – it had tested. The online pharmacy also asserted that the instability of the ranitidine molecule results in the production of NDMA when the drug is subjected to conditions that mimic human digestion.
Months later, Emery Pharma reported that its own testing suggested the carcinogen was produced when ranitidine products were exposed to high temperatures typically encountered during shipment and storage.
In April 2020, the U.S. Food & Drug Administration (FDA) ordered all Zantac and generic ranitidine drugs recalled. By then, however, many pharmaceutical companies had already taken steps to withdraw their ranitidine-containing heartburn drugs from the market. Several major retailers, including Walmart, Walgreens, Rite-Aid, and CVS, had also stopped selling the medications.
More than 570 Zantac lawsuits are now pending in a multidistrict litigation underway in the U.S. District Court, Southern District of Florida, all of which allege the ingestion of ranitidine-containing medications contributed to the development of cancer. Plaintiffs further claim that the various defendants had long known that ranitidine could expose users to dangerous levels of NDMA but failed to disclose this risk to doctors and patients.