Zantac, once a top-selling drug, is now embroiled in a legal battle. Glaxo (now GSK) allegedly hid cancer risks associated with the drug despite warnings. The rise and fall of Zantac expose corporate secrecy and regulatory oversights.
The Birth of Zantac and Early Warnings

Zantac, or ranitidine, was created by Glaxo Labs in the late 1970s to rival Tagamet. Despite early safety concerns, Zantac became a top-selling drug by the 1980s. Glaxo allegedly downplayed risks of the drug to focus on profits.
In 1981, Glaxo’s study confirmed Zantac’s ability to form the carcinogen NDMA. The company chose to keep this information hidden from the FDA. Zantac was approved in 1983 without FDA knowledge of the risks.
The Hidden Dangers of NDMA

NDMA, a potent carcinogen, was linked to cancer in the 1970s. Glaxo was aware of NDMA formation in Zantac but did not disclose this to FDA. In 2019, Valisure found high NDMA levels in Zantac, leading to recalls and FDA withdrawal in 2020.
Decades of Concealment and Flawed Research

GSK ignored warnings about NDMA risks in Zantac and supported flawed research to downplay concerns. In 2020, the FDA removed all ranitidine products from the market after GSK finally released the hidden 1982 study confirming NDMA formation.
Legal Battles and Ongoing Controversy

Over 70,000 lawsuits are filed against GSK for alleged cancer links to Zantac. While a federal court dismissed many cases in 2022, state courts continue the legal battles. The FDA’s stance on Zantac’s cancer risk is criticized, with ongoing research connecting ranitidine to various cancers.
Conclusion

Zantac’s saga warns of the dangers when profits outweigh health. GSK’s alleged cover-up jeopardized public safety, leading to ongoing legal battles. The pharmaceutical industry must prioritize transparency and accountability to safeguard public health.
Sources
- “Zantac’s Maker Kept Quiet About Cancer Risks for 40 Years.” Bloomberg. Anna Edney, Susan Berfield, and Jef Feeley. February 15, 2023.
- “GSK was warned repeatedly about Zantac impurity but played down risks: Bloomberg.” Fierce Pharma. Eric Sagonowsky. February 15, 2023.
- “Risks of Zantac Were Kept Quiet for 40 Years.” Med Legal