Bloomberg Blasts GSK Over Handling of Zantac’s Cancer Risks

Nearly three years after the FDA pulled all ranitidine products off the shelves due to suspected links to a carcinogen, GSK, the maker of the most famous ranitidine product, Zantac, is facing tens of thousands of lawsuits surrounding the issue. A recent investigative report published by Bloomberg highlighted some of the most concerning problems with the case, including the potentially dangerously high levels of a known carcinogen, NDMA, found in ranitidine. 

The Rapid Rise and Fall of Zantac

Originally approved in 1983 as a prescription drug to treat acute duodenal ulcers and later as a general heartburn remedy, Zantac dominated the market, quickly overtaking its rival, Tagamet. Six years after its approval, Zantac was worth $2 billion, making it one of the most profitable drugs in history. By 1996, the FDA approved Zantac as an over-the-counter medication, expanding the drug’s heartburn empire.

After decades of success with few mainstream safety concerns, an independent laboratory notified the FDA that it had found NDMA in ranitidine in 2019. The discovery prompted an investigation into ranitidine, and the FDA responded quickly, pulling all ranitidine products from the shelves. 

In April 2020, the FDA published its official removal request for all ranitidine products from the market, citing concerns over the contaminant N-Nitrosodimethylamine (NDMA) found in the products. The agency also expressed concerns over the storage methods of the drug, stating NDMA can increase over time in products stored in higher than room temperature conditions. 

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Uncovering the Possible Link Between Ranitidine and Cancer

NDMA is common in a normal diet, often found in water and some foods; however, increased levels of the contaminant are known to lead to cancer. So much so that scientists often use NDMA to induce tumors in mice in drug development programs. 

According to the Bloomberg article, the FDA said it detected 357ng of NDMA in an over-the-counter version of Zantac, a level nearly four times higher than what is acceptable in any FDA-approved drug. To make matters worse, the NDMA levels increased to 931ng in the same product five months after initial testing. 

With lawsuits flooding GSK, several people around the country are coming forward with stories about how Zantac may have affected them. Brent Wisner, an attorney representing a plaintiff with cancer, claims that one of the Zantac pills in his possession contains over 3,000ng of NDMA.

Even with the troubling figures, a U.S. judge dismissed thousands of federal lawsuits surrounding Zantac in December last year, declaring that there is no widespread evidence linking ranitidine and cancer. Still, state courts are not bound by the federal ruling, so GSK still faces tens of thousands of cases, which will likely take several years to get through. Additionally, several other pharmaceutical companies like Pfizer and Sanofi face similar lawsuits for selling Zantac in later years. 

Author

Reed Slater