The complex contaminant, which results from poorly-understood chemical reactions, has been found in GSK and Sanofi’s Zantac products, and trial judgments could climb to $45 billion, according to a Morgan Stanley report Bloomberg cited. Pfizer, Merck and Sandoz have recently recalled medications due to traces of nitrosamines, which has been linked to cancer in animal trials.
It’s a relatively new issue. The compound was first detected in 2018, and since then, more than 250 recalls related to nitrosamines have been reported to the FDA, according to Bloomberg. As drugmakers scurry to ensure their products are free of the contaminant, the FDA advises physicians to continue prescribing drugs with low levels of nitrosamines as long as they aren’t part of a recall.
A big question for pharmaceutical companies is which products to investigate, because nitrosamines have been found in a plethora of drugs, including medications for blood pressure, Type 2 diabetes, tuberculosis and managing pain.
“What’s troubling is the number of drugs where this is showing up,” Michael Carome, MD, director of Public Citizen’s health research group, told Bloomberg. “If there’s a large settlement brought against the makers of Zantac, it’s possible that could trigger lawsuits against other drugs that have been contaminated with carcinogens.”
As the FDA continues to investigate the potential link between nitrosamines and the risk of cancer, GSK and Sanofi’s Zantac trial is set for February, and more are planned in 2023.
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