Several different manufacturers of Zantac face a lawsuit that alleges side effects of the popular heartburn drug resulted in the development of kidney cancer, due to carcinogenic chemicals that may develop in the tablets.

The complaint (PDF) was filed by Shawn Lorenzo Francis in the U.S. District Court for the Eastern District of Pennsylvania on October 16, which is believed to be one of the first cancer lawsuits filed over the discovery of the chemical byproduct N-nitrosodimethylamine (NDMA) in Zantac.

Defendants named in the complaint include Boehringer Ingelheim, Sanofi U.S. Services, Inc. and Chattem, Inc. as defendants, which have sold and distributed versions of Zantac for years that may have exposed users to high levels of NDMA, which the World Health Organization has described as “clearly carcinogenic.”

Zantac (ranitidine) has been on the market for decades, and is widely used by millions of Americans for treatment of heart burn and acid reflux. However, multiple manufacturers have recalled Zantac in recent weeks, after testing confirmed that the active ingredient may convert to NDMA when exposed to high temperatures, such as in a car or inside the human stomach.

NDMA is a chemical byproduct, which has been linked to reports of kidney cancer, stomach cancer, bladder cancer, small intestine cancer, liver cancer and other digestive tract cancers.

While the FDA’s permissible daily intake limit for NDMA is 96 ng, the complaint indicates that consumers taking a typical eight-week course of Zantac to treat peptic ulcer disease may be exposed to more than 280,000,000 ng of NDMA, and users taking a 150 mg maintenance dose of Zantac daily are exposed to 889,000,000 ng over the course of a year.

According to the lawsuit, Francis began taking over-the-counter Zantac in 2007 and continued to use the drug through 2019, taking it four or more times per week. He was diagnosed with kidney cancer in 2015.

“Plaintiff did not learn of the link between his cancer and Zantac exposure until September 30, 2019, when he learned that Zantac contained high levels of NDMA by watching the news,” the lawsuit states. “After being diagnosed with cancer, Plaintiff investigated what could have caused his cancer, but to no avail until recently when he heard about the connection of Zantac to NDMA and cancer.”

The problem was first reported in the U.S. by the online pharmacy Valisure, which filed a citizen’s petition calling for a Zantac recall in September. Shortly after, the FDA issued a warning about the potential risk of Zantac NDMA contamination, indicating that the agency is continuing to investigate the issue.

The case joins a number of recently filed class action lawsuits, which seek damages for all purchasers of the recalled heartburn drug. However, it is the first of what is expected to be hundreds, if not thousands, of individual Zantac cancer lawsuits that are likely to be filed in the coming months and years, alleging that a diagnosis could have been avoided if other available heartburn drugs had been used.

Tags: Boehringer Ingelheim, Cancer, Heartburn, Heartburn Drug, Kidney Cancer, NDMA, Sanofi, Zantac