Zantac maker settles 4,000 lawsuits linking discontinued heartburn drug to cancers

The maker of a discontinued heartburn medication has settled thousands of lawsuits that claim the pills cause cancer. 

New Jersey-based manufacturer Sanofi has reached an agreement to settle 4,000 lawsuits linking the active ingredient in Zantac - rantidine - to cancers.

Zantac, an over-the-counter pill for heartburn and indigestion, was pulled from shelves in 2020 after animal studies found that rantidine released 'probable human carcinogens' linked to esophageal, kidney, and colorectal cancer.  

Sanofi did not admit any wrongdoing and said that it settled to avoid the expenses and distractions of litigation. 

The company also did not announce how much they would pay out to plaintiffs.  

Sanofi, drugmaker behind discontinued heartburn medication Zantac, agreed to settle 4,000 lawsuits alleging that the drug's active ingredient created cancer-causing chemicals 

'Sanofi has vigorously defended the Zantac litigation since the outset and will continue to do so,' the company said. 

Zantac was first approved in 1983 and developed by GSK, becoming the world's fastest selling medication in 1988. In 2016, Sanofi acquired the treatment in an asset swap with Boehringer Ingelheim.

However, Sanofi recalled Zantac in 2019 after studies found that rantidine was creating toxic levels of N-Nitrosodimethylamine (NDMA).  

NDMA is a chemical byproduct of many industrial manufacturing processes, including the production of rocket fuel.

It's also common in low quantities in many foods, such as cured or smoked meats, fish and beer as well as tobacco smoke. 

NDMA is a 'forever chemical,' meaning that it doesn't degrade, or break down, naturally in the environment or our bodies. Over time, it accumulates, and our exposures build up.

A number of theories have been put forward to explain how the toxic chemical ended up in the supply of some heartburn medications, as well as in the blood pressure drugs, valsartan and losartan, in recent years.

READ MORE: FDA says ALL Zantac must be pulled from shelves months after officials warned the drug is contaminated with cancer-causing chemicals 

US health official are demanding drugmakers immediately pull their popular heartburn drugs off the market after determining that a contamination issue with the medications poses a greater risk than previously thought. 

Some have suggested it's due to poor manufacturing, while others have initially suggested that the way the body metabolizes the drug could actually make levels of NDMA surge in the stomach. However, the latter theory was debunked in 2019.

Animal studies have shown that NDMA can increase the risk of cancers in the esophagus, kidneys, and stomach. They have also been linked to colorectal cancer, which is on the rise among young Americans. 

There have been no cancer cases officially linked to Zantac, the WHO states, though thousands of patients have alleged otherwise.

In 2020, Deborah Haskins of Virginia claimed the the drug, which she had been using since 2005, was responsible for her esophageal cancer.  

Ms Haskins said that ranitidine's chemical structure is 'inherently unstable' and can break down during digestion and produce the cancer-causing agent NDMA. 

Joseph Galimidi, a rabbi from South Florida, sued for compensation for injuries, pain and suffering after developing breast cancer in 2013, which is rare in men.

Mr Galimidi said he had been regularly taking Zantac for heartburn over the previous four years.

And Mark Allan Blake, of Colorado, filed a lawsuit claiming that Zantac, which he began using four times weekly in 1996, was responsible for causing the bladder cancer he developed in 2018.

The FDA ordered all products with rantidine be removed from shelves in 2020 and urged patients to stop taking any medications containing the ingredient.

Sanofi still faces 20,000 lawsuits over Zantac in Delaware state court, where 70,000 cases were filed against Sanofi and GSK, Pfizer, and Boehringer Ingelheim.

Jennifer Moore and Brent Wisner, who are the lead plaintiffs’ attorneys in the Delaware and California litigation, said Wednesday that they were pleased that Sanofi had reached a settlement while litigation continues against other defendants.

'We are pushing forward aggressively against GSK and Boehringer Ingelheim and are preparing for multiple trials in California state court this year,' Ms Moore said.

Sanofi now sells Zantac360, a reformulated heartburn medicine whose active ingredient is famotidine