The maker of a discontinued heartburn drug has settled thousands of lawsuits claiming the pills cause cancer.
New Jersey-based manufacturer Sanofi has reached an agreement to resolve 4,000 lawsuits linking Zantac’s active ingredient, rantidine, to cancer.
Zantac, an over-the-counter pill for heartburn and indigestion, was pulled from shelves in 2020 after animal studies found rantidine released “probable human carcinogens” linked to esophageal, kidney and colorectal cancer.
Sanofi did not admit wrongdoing and said it settled to avoid the expense and distraction of litigation.
The company also did not announce how much it would pay the plaintiffs.
Sanofi, the drugmaker behind the discontinued heartburn drug 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 from the beginning and will continue to do so,” the company said.
Zantac was first approved in 1983 and developed by GSK, becoming the world’s best-selling drug in 1988. In 2016, Sanofi acquired the treatment in an asset swap with Boehringer Ingelheim.
However, Sanofi withdrew Zantac in 2019 after studies found rantidine created toxic levels of N-nitrosodimethylamine (NDMA).
NDMA is a chemical byproduct of many industrial manufacturing processes, including rocket fuel production.
It is also common in small amounts in many foods, such as cured or smoked meats, fish, and beer, as well as in tobacco smoke.
NDMA is a “forever chemical,” meaning it does not degrade or break down naturally in the environment or in our bodies. Over time, it accumulates and our exposure increases.
Several theories have been proposed to explain how the toxic chemical ended up in the supply of some heartburn medications, as well as the blood pressure medications valsartan and losartan, in recent years.
Some have suggested it is due to poor manufacturing, while others have initially suggested that the way the body metabolizes the drug could actually cause NDMA levels to increase in the stomach. However, this last theory was debunked in 2019.
Animal studies have shown that NDMA may increase the risk of esophageal, kidney, and stomach cancer. They have also been linked to colorectal cancer, which is increasing among young Americans.
There have been no cases of cancer officially linked to Zantac, the WHO says, although thousands of patients have claimed otherwise.
In 2020, Deborah Haskins of Virginia claimed that the drug, which she had been using since 2005, was responsible for her esophageal cancer.
Ms Haskins said ranitidine’s chemical structure is “intrinsically unstable” and can break down during digestion and produce the carcinogen NDMA.
Joseph Galimidi, a South Florida rabbi, sued in 2013 for compensation for injuries, pain and suffering after developing breast cancer, which is rare in men.
Galimidi said he had been taking Zantac regularly for heartburn for the previous four years.
And Mark Allan Blake of Colorado filed a lawsuit alleging that Zantac, which he began using four times a week in 1996, was responsible for causing the bladder cancer he developed in 2018.
The FDA ordered all rantidine products off shelves in 2020 and urged patients to stop taking any medications containing the ingredient.
Sanofi still faces 20,000 Zantac lawsuits in Delaware state court, where 70,000 cases have been filed against Sanofi and GSK, Pfizer and Boehringer Ingelheim.
Jennifer Moore and Brent Wisner, who are lead attorneys for the plaintiffs in the Delaware and California litigation, said Wednesday they were pleased that Sanofi had reached a settlement while litigation against other defendants continues.
“We are moving aggressively against GSK and Boehringer Ingelheim and are preparing for multiple trials in California state court this year,” Ms. Moore said.
Sanofi now markets Zantac360, a reformulated heartburn medication whose active ingredient is famotidine.