Is Zantac linked to cancer?

Zantac—and its generic equivalent Ranitidine—was introduced into the marketplace in the 1980s as offering relief to those suffering from heartburn, acid indigestion, gastric ulcers and other gastrointestinal conditions. Since its emergence on the market, the manufacturers and distributors of Zantac have frequently claimed it was a safe and effective treatment for infants, children, adults, and the elderly.

Now, independent researchers, working alongside the FDA, have discovered that just a single dose of Zantac has been shown to break down inside the body into extreme levels of NDMA—a volatile cancer causing agent. After decades of misrepresenting and hiding the scope of the problem, the cancerous propensities of Zantac started coming to light. Following the FDA’s April 1, 2020 recall of Zantac and Ranitidine, with the knowledge of the danger finally being provided to the public, numerous consumers across the country are left with fear, concern, and worry that their use of this drug has exposed them to unacceptable levels of NDMA.  

A Brief History of Zantac and Ranitidine.

Zantac was developed by GlaxoSmithKline, LLC and approved for prescription use by the FDA in 1983. The drug belongs to a class of medications called histamine H2-receptor antagonists (or H2 blockers), which decrease the amount of acid produced by the stomach. Within a few short years, Zantac was being ingested regularly across the country, becoming the world’s best-selling drug in 1988. Zantac became available without a prescription in 1996, and generic versions of the drug (ranitidine) became available the following year. As of 2016, Zantac was the 50th most prescribed drug in the United States with over 15 million prescriptions.

Valisure LLC, an online pharmacy with a mission to help ensure the safety, quality and consistency of medications and supplements, began conducting quality checks on batches of Zantac and other Ranitidine drugs in the last few years. Alarmingly, through these tests, Valisure detected extremely high levels of NDMA in every lot tested, across multiple manufacturers and dosage forms of Ranitidine. The FDA has established a permissible daily intake limit for NDMA of 96 nanograms. Valisure has detected NDMA in excess of 3,000,000 nanograms per tablet when analyzing Ranitidine products, including Zantac.

On September 9, 2019, Valisure LLC submitted a petition to the FDA detailing these findings and within weeks U.S. and European regulators announced that they were reviewing the safety of Ranitidine. On September 18, 2019, a generic Ranitidine manufacturer stated that it was halting the distribution of its versions of Zantac in all markets, while Canada requested drug makers selling ranitidine to stop distribution. By the end of the month, CVS Health Corp., Walmart, Inc., Walgreens, and Rite Aid Corp had removed Zantac and Ranitidine products from their shelves.

Ultimately, on April 1, 2020 the FDA announced the withdrawal of all Zantac and Ranitidine drugs from the market immediately. This was considered the latest step in an ongoing investigation into NDMA in Zantac and other Ranitidine medications, as the drugs’ impurities resulted in consumer exposure to unacceptable levels of this cancerous compound.

The Dangers of NDMA

NDMA is a semi-volatile organic chemical that forms in both industrial and natural processes. Modernly, the only permissible use of NDMA is for the purposes of inducing tumor growth in laboratory animals.

Both the Environmental Protection Agency and the International Agency for Research on Cancer have classified NDMA as a probable carcinogen. The World Health Organization has stated that scientific testing indicates that NDMA consumption is positively associated with a range of cancers and suggests that humans may be especially sensitive to the carcinogenicity of NDMA.

The FDA also recognizes the danger of such compounds and, as a result, has set strict daily acceptable intake limits on NDMA in pharmaceuticals. In accordance with these limits, a multitude of manufacturer recalls of pharmaceutical drugs have occurred due to the detection of NDMA. In an apparent effort to avoid this fate, researchers have determined that weaknesses in testing methodology by the manufacturers of Zantac and Ranitidine likely enabled its presence in these drugs to go undetected. This was possible because the extreme levels of NDMA produced by Zantac are not caused by any contamination but rather are inherent to the drug’s molecular structure. Zantac’s ranitidine molecule contains both nitrite and dimethylamine which are well known to combine to form NDMA. Thus, ranitidine produces NDMA by “react[ing] with itself,” such that every dosage and form of Ranitidine, including Zantac, exposes users to NDMA.

Consequently, under general use conditions, a single dose of a 150 mg Zantac pill was found to contain 245 to 3,100 times above the FDA-allowable limit of NDMA. Echoing this finding, a study completed and published in 2016 by Stanford University observed that healthy individuals, both male and female, who ingested Zantac 150 mg tablets produced roughly 400 times elevated amounts of NDMA in their urine (over 47,000 ng) in the proceeding 24 hours after ingestion.

What to Do

If you or a loved one have been diagnosed cancer as a result of ingesting Zantac or Ranitidine, please call Cowper Law LLP at 877.LAW.3707 to speak with an attorney about your rights. We are attorneys with experience in pharmaceutical drugs and product liability litigation. Let us help fight for you.