Sanofi has in principle reached a settlement related to its discontinued heartburn drug Zantac, though the French pharma did not disclose the financial terms of the deal.
Sanofi has reached a settlement agreement for around 4,000 lawsuits regarding claims that its discontinued heartburn drug Zantac (ranitidine) caused cancer, according to several media reports Wednesday.
The French pharma did not disclose the terms of the deal, including the specific settlement amount, but revealed that it would resolve most of the Zantac-related lawsuits across all U.S. state courts outside of Delaware, where most of the cases are still pending, according to reporting by Reuters.
While Sanofi is still in the process of finalizing the deals, the company insists that it has no liability in the matter and is only settling to stem other expenses and distractions associated with the case. “Sanofi has vigorously defended the Zantac litigation since the outset and will continue to do so,” a company spokesperson told Reuters in a statement.
More than 70,000 Zantac cases—against Sanofi and other drugmakers—still hang in the balance and are being reviewed in the Delaware Superior Court, according to Reuters.
Zantac is a histamine 2-receptor antagonist that works by lowering the secretion of gastric acid, the main driver of heartburn. Originally developed by Glaxo Holdings, which now forms part of GSK, the drug was first approved in 1983 and became the world’s top-selling drug five years later, according to a 2019 analysis by Reuters.
Later, competitors would develop generic alternatives to Zantac, hoping to share in its sales. Eventually, through a series of deals and transactions, Zantac would come to be owned by Sanofi.
In 2019, the FDA alerted healthcare professionals and patients to potential NDMA contamination found in several samples of ranitidine, the active ingredient in Zantac and its iterated versions.
NDMA is an environmental contaminant typically found in water and foods, including dairy products, meat and vegetables. The FDA classifies NDMA as a probable human carcinogen, indicating that it “could” cause cancer.
At the time of the FDA’s alert, the regulator played the risks down noting that patients could “trust that their medicines are safe” and that the NDMA levels present in ranitidine “barely exceed amounts you might expect to find in common foods.”
However, in April 2020, the FDA called on ranitidine manufacturers to pull their products—both prescription and over-the-counter formulations—from the market. The regulator found that the concentrations of the NDMA impurities could increase over time in some products, especially when stored at higher temperatures, and this could lead to consumers being exposed to unacceptable levels of NDMA.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
