A man who took the heartburn medication Zantac for years has filed a lawsuit against its manufacturers, Sanofi-Aventis, GlaxoSmithKline, Boehringer Ingelheim Pharmaceuticals, and Sanofi, accusing the companies of knowingly misrepresenting its widely popular drug as safe despite knowing that it “produced a toxic carcinogen when ingested,” Newsday reports.

In their Zantac class action lawsuit, plaintiffs Douglas and Anna Maria R. say that Douglas took the heartburn medication about four-to-five times per week for five years, beginning in 2014,  Douglas developed bladder cancer and had to undergo multiple surgeries to treat it.

He claims that his bladder cancer was the result of his Zantac use, and seeks to hold the drugmakers accountable for his injuries. The couple accuses the drugmakers of putting profits ahead of patient health and is asking for damages in excess of $75,000 for “lost earnings, medical expenses, pain and suffering, and legal fees,” according to Newsday.

Douglas and Anna Maria claim that the defendants were aware that the medication could produce NDMA, a known carcinogen, yet they concealed this information from the U.S. Food and Drug Administration (FDA), medical professionals, and patients, instead, advertising the drug to be safe. The suit states that had Douglas known that the drug could produce a carcinogen, he never would have agreed to take it.

Douglas claims that he and his physicians relied on the defendants’ representation of the drug as safe. Allegedly, the drug companies knew that its drug was not safe for human consumption, but marketed and sold it nonetheless. The FDA issued a notice in April that the drug would be taken off the market due to the concerns of NDMA.

Zantac is advertised for use to treat gastric ulcers, heartburn, indigestion, sour stomach, and other gastrointestinal issues. The Zantac bladder cancer class action lawsuit notes that Zantac was “one of the first global blockbuster drugs” when it was introduced to the market in 1983, and remains one of the 100 best-selling prescription drugs in the United States.

However, the Zantac cancer risk lawsuit asserts that this popularity was ill-gotten. The drug reportedly produces NDMA when ingested. NDMA has been shown to produce cancer in lab rats and is also a waste product in the production of rocket fuel, according to Newsday.  NDMA metabolizes in the body into other nefarious chemicals including formaldehyde.

NDMA contamination in medications has been the source of much concern. The substance was found in the blood pressure medication valsartan. However, while the NDMA in valsartan was determined to be the result of a manufacturing problem, the NDMA in Zantac is allegedly catalyzed in the drug itself.

Suit Says NDMA Causes Cancer, Including Bladder Cancer

Douglas and Anna Maria assert that since Zantac first came on the market, its makers were aware that it could produce a carcinogen. Since the drug’s makers were looking for a successor to an earlier heartburn drug, they were aware that drugs like ranitidine (Zantac) were “highly likely to form NDMA when combined with substances found in the body, such as nitrites.”

Douglas and Anna Maria accuse the defendants of actively attempting to discredit research showing that ranitidine could produce NDMA, saying that the drugmakers attempted to publish flawed, altered research to show that ranitidine was safe.  

The Zantac NDMA Bladder Cancer Lawsuit is Case No. 9:20-cv-80664-XXXX, in the U.S. District Court for the Southern District of Florida.