Zantac’s Maker Kept Quiet About Cancer Risks for 40 Years

Zantac, once one of the world’s best-selling drugs, is now at the center of a massive legal battle. For decades, its manufacturer, Glaxo (now GlaxoSmithKline or GSK), allegedly concealed the potential cancer risks associated with the drug, despite warnings from their own scientists and independent researchers. The story of Zantac’s rise and fall reveals a troubling narrative of corporate secrecy, flawed research, and regulatory oversights.

The Birth of Zantac and Early Warnings

Zantac, also known as ranitidine, was developed by Glaxo Laboratories in the late 1970s as a competitor to the ulcer drug Tagamet. It quickly became a blockbuster, overtaking Tagamet to become the world’s top-selling prescription medication by the 1980s.¹ However, even before the drug hit the market, concerns about its safety were raised.

As early as 1980, researchers suggested that under certain conditions in the stomach, ranitidine could form a potentially dangerous compound called N-Nitrosodimethylamine (NDMA), a probable human carcinogen. Despite these concerns, Glaxo moved forward with their plans to market Zantac, downplaying the risks and focusing on the drug’s profitability.

Read More: 10 Things Cancer Survivors Want You to Know About Chemo

The Hidden Dangers of NDMA

NDMA is a potent carcinogen known to cause cancer in every species of animal tested. It was first linked to cancer in 1956, and by the 1970s, it was considered one of the most dangerous carcinogens discovered. Studies indicated that NDMA could form in the stomach when nitrites, common in foods and medications, combined with amines, compounds present in many drugs, including ranitidine.

In 1981, Glaxo conducted a study that confirmed the formation of NDMA when ranitidine was mixed with nitrites. However, instead of disclosing these findings to the U.S. Food and Drug Administration (FDA), Glaxo chose to keep the study results secret. The FDA approved Zantac in 1983, unaware of the full extent of the potential risks.

Decades of Concealment and Flawed Research

Over the years, GSK was repeatedly warned about the risks of NDMA formation in Zantac. Despite these warnings, the company supported flawed research designed to minimize concerns and opted not to make changes to its manufacturing or storage processes that could have mitigated the problem.² Ranitidine, the active ingredient in Zantac, was known to be unstable, especially when exposed to heat and humidity, conditions that could cause it to degrade and form NDMA.

In 2019, an independent lab, Valisure, found alarmingly high levels of NDMA in Zantac and its generic versions. This discovery led to widespread recalls and eventually prompted the FDA to pull all versions of ranitidine from the market in 2020.³ It was only then that GSK released the study it had kept hidden since 1982, confirming the formation of NDMA in ranitidine.

Read More: 14-Year-Old Invents Soap To Treat Skin Cancer – Wins Top Science Prize

Legal Battles and Ongoing Controversy

Today, GSK and other drug manufacturers face more than 70,000 lawsuits in state courts across the United States, with plaintiffs alleging that Zantac caused their cancers. Despite a federal court ruling in 2022 that dismissed thousands of these cases, citing a lack of reliable evidence, state courts are not bound by this decision, and the legal battles are far from over.

The FDA maintains that there are “no consistent signals” that Zantac increases cancer risk, a position based on limited studies that have been criticized for their methodologies. However, new research continues to emerge, linking ranitidine to various cancers, including bladder and liver cancers.

Conclusion

The story of Zantac is a cautionary tale of what can happen when corporate profits are prioritized over public health. For decades, GSK allegedly concealed critical information about the risks associated with Zantac, exposing millions of people to a potential carcinogen. As the legal battles continue, the full extent of the harm caused by Zantac is still being uncovered. The case underscores the need for greater transparency and accountability in the pharmaceutical industry to ensure that public health is never compromised.

Read More: Cancer Rates Rising in Gen X and Millenials Compared to Older Generations, Study Finds