A Kentucky woman who was diagnosed with stomach and liver cancer following years of Zantac use is suing the manufacturers of the popular heart burn medication.
According to a March 6th filing in the U.S. District Court, Eastern District of Kentucky, Vicki Sherbet used Zantac (ranitidine) and generic equivalents for approximately 8 years, during which time she took 150-300 mg every day. She was subsequently diagnosed with stomach and liver cancer, which the lawsuit attributes to the presence of N-Nitrosodimethylamine (NDMA) in Zantac. (Case No.9:20-cv-80459-RLR)
Sherbet claims that, while Zantac was still in development, GlaxoSmithKline was aware of data suggesting ranitidine would produce NDMA when combined with other substances, such as nitrate, already present in the human body. As such, she asserts it was foreseeable that a failure to update the drug’s label would cause injury to patients using Zantac, including stomach and liver cancer.
“At no time did any Defendant attempt to include a warning about NDMA or any cancer, nor did the FDA ever reject such a warning. Defendants had the ability to unilaterally add an NDMA and/or cancer warning to the Zantac label (for both prescription and OTC) without prior FDA approval pursuant to the Changes Being Effected regulation,” the complaint continues. “Had any Defendant attempted to add an NDMA warning to the Zantac label (either for prescription or OTC), the FDA would not have rejected it.”
In addition to GlaxoSmithKline, Sherbert’s Zantac lawsuit seeks compensation from several other drug manufacturers, including: Boehringer Ingelheim, Sanofi US, Chattem, Inc., and Pfizer, Inc.
GlaxoSmithKline introduced Zantac in 1986, and in just two years, it became the first prescription medication to surpass $1 billion in annual sales. Since then, numerous generic drug makers have launched their own versions of ranitidine, both over-the-counter and prescription.
In 2019, the FDA warned that Zantac and generic ranitidine products could contain excessively high levels of NDMA, a probable human carcinogen. The agency was alerted to the issue by Valisure, an online pharmacy that found NDMA in every sample of Zantac and ranitidine it tested, and often at levels far higher than the FDA’s recommended daily limit of 96 nanograms. Valisure also asserted that the impurity resulted from the ranitidine molecule’s instability, which apparently produced NDMA when subjected to conditions that mimic human digestion.
Valisure petitioned the FDA for a Zantac recall, but the agency is still studying the issue and has not ordered any such actions. Nevertheless, many drug makers have opted to voluntarily recall their Zantac and ranitidine products, while retailers around the country – including CVS, Walmart, Walgreens, and Rite-Aid — have pulled the drugs from store shelves.