GSK Reaches $2.2 Billion Settlement in Zantac Cancer Lawsuits

GlaxoSmithKline (GSK) has reached a substantial settlement agreement to resolve a large majority of the lawsuits alleging that its once-popular heartburn medication, Zantac, caused cancer.

The pharmaceutical company will pay up to $2.2 billion to resolve approximately 80,000 cases, which represents around 93% of the Zantac litigation pending in U.S. state courts. This settlement marks a major development in the ongoing legal proceedings over Zantac, a drug that was once a global top seller. However, as part of the agreement, GSK does not admit any liability or wrongdoing.

The litigation stems from concerns that Zantac's active ingredient, ranitidine, could degrade into NDMA, a known carcinogen, under certain conditions, such as over time or when exposed to heat. This discovery prompted the U.S. Food and Drug Administration (FDA) to request in 2020 that all manufacturers withdraw Zantac from the market.

From Top-Selling Heartburn Drug to Cancer Concerns

Zantac, first approved in 1983, quickly gained widespread use as an effective treatment for heartburn and acid reflux. By 1988, it had become the world's top-selling medicine and one of the first to surpass $1 billion in annual sales. Its availability both over-the-counter and by prescription made it a common fixture in medicine cabinets across the globe.

However, the discovery of the potential link between ranitidine and NDMA changed the course of Zantac's story. NDMA, or N-Nitrosodimethylamine, is a potent carcinogen that has been linked to various cancers in animal studies. It is classified as a probable human carcinogen by the International Agency for Research on Cancer (IARC).

While NDMA is found in some foods and water supplies at low levels, exposure to higher levels can increase the risk of developing cancer. The concerns about Zantac stemmed from the finding that ranitidine could degrade into NDMA under certain conditions, potentially exposing users to unsafe levels of this carcinogen.

This led to voluntary recalls of Zantac by manufacturers and eventually culminated in the FDA's market withdrawal request in 2020.

Lawsuits Allege Zantac Manufacturers Failed to Warn Consumers of Cancer Risk

Following the recalls and market withdrawal, individuals who had used Zantac and subsequently developed cancer began filing lawsuits against GSK and other manufacturers of the drug.

Plaintiffs alleged that Zantac caused various types of cancer, including bladder, liver, stomach, and esophageal cancer. They claimed that the companies knew or should have known about the risks associated with NDMA formation in ranitidine but failed to adequately warn consumers.

The lawsuits asserted that GSK and other manufacturers had a duty to ensure the safety of their products and that they breached this duty by selling Zantac when they knew or should have known about the potential cancer risk. Plaintiffs sought compensation for their medical expenses, lost income, pain and suffering, and other damages.

GSK Zantac Settlement Follows Agreements With Other Manufacturers

The settlement with GSK follows similar agreements reached by other manufacturers of Zantac. In August 2024, Pfizer settled approximately 10,000 Zantac lawsuits for an undisclosed amount. Earlier in April, Sanofi also settled 4,000 lawsuits for an undisclosed amount.

Important Note for Consumers: It is important to remember that the product currently marketed as Zantac uses a different active ingredient, famotidine, and does not contain ranitidine. If you have concerns about medications you have taken in the past or are currently taking, it is always advisable to consult with your doctor or another healthcare professional.