Rosenbaum & Rosenbaum, P.C. | November 1, 2019 | Defective Drugs
The U.S. Food and Drug Administration (FDA) publicly announced in September 2019 that dangerously high levels of the carcinogenic substance N-Nitrosodimethylamine (NDMA) have been found in the popular over-the-counter heartburn medication, Zantac. This means that millions of people who have been taking Zantac have regularly been ingesting a chemical that is notorious for causing cancer.
Pharmaceutical giants Sanofi and Boerhringer Ingelheim, who are responsible for manufacturing and distributing Zantac, have been accused of marketing this medication while knowing it contained the cancer causing chemical.
Zantac is the popular trade name for Ranitidine, a medication that reduces the body’s production of stomach acid. Zantac is available both over-the-counter and by prescription and is one of the most popular drugs available in the United States. In 2018, sales of over-the-counter Zantac were greater than $129 million. Zantac has been on the market for decades, and is regularly used by millions of Americans to treat heart burn and acid reflux. However, there has been an overwhelming amount of new evident to suggest that the active ingredient in Ranitidine is inherently unstable and may convert to NDMA when stored at high temperatures, such as inside the human stomach.
What is NDMA?
NDMA is a potential hepatotoxic and is known to be highly toxic to the human body, especially the liver. The World Health Organization has stated that “there is conclusive evidence that NDMA is a potent carcinogen.” The Environmental Protection Agency has classified NDMA as “extremely hazardous” and there are strict reporting requirements for companies and individuals who produce, store, or use NDMA in large quantities. The FDA’s September 2019 public announcement stated that Zantac and the generic Ranitidine contained “unacceptable” levels of NDMA. According to independent testing by the online pharmacy Valisure, levels of NDMA in one Zantac 150mg tablet may exceed 3,000,000 nanograms (ng), which is 26,000 times higher than the FDA’s permissible daily intake for the chemical. The FDA’s permissible daily intake limit for NDMA is 96 ng, but users taking the 150 mg maintenance dose of Zantac daily are exposed to 889,000,000 ng over the course of a year. Excessive levels were detected across all brands of Zantac, and Valisure indicated research dating back 20 years has included warning signs about potential problems with the drug.
Retail pharmacies CVS, Walgreens, and Rite-Aid have taken swift action to voluntarily and preventatively remove Zantac and the generic alternatives from their stores after the FDA announcement. In October, Sanofi issued a voluntary recall on Zantac over-the-counter in the United States. Pharmaceutical companies and federal regulators indicate they are continuing to investigate the Zantac problems. Valisure testing confirmed that no detectable levels of NDMA were found in eight other popular alternatives to Zantac, including Tagamet, Pepcid, Prilosec, Nexium, Prevacid, Protonix, AcipHex and Dexilant. If you are taking Zantac or Ranitidine this is something that should be closely monitored as the FDA continues their ongoing investigation and releases new information.
If you have taken Zantac or Ranitidine in the past, and would like to discuss your potential case, we encourage you to contact one of our attorneys at .