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In March 1988, Glaxo commissioned a Gallup Poll titled “Heartburn Across America,” It found 44% of the adult population suffered heartburn monthly. Zantac could be prescribed for heartburn by then, but plenty of antacids were available that didn’t require a prescription. Glaxo promoted the survey on television and in print. The ads noted that heartburn and other symptoms of chronic reflux could signal diseases such as ulcers and suggested seeing a physician.
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Zantac’s sales in the US that first year were about $125 million, which made it one of the best launches of a drug ever.
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Glaxo also knew of another potentially serious problem with ranitidine. It wasn’t always stable. The drug was sensitive to heat and humidity, and when exposed to too much of either could degrade.
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In a summary later reviewed by the FDA, Glaxo scientists wrote that yes, high levels of nitrite could form nitrosamines, almost ali ofwhich are carcinogens.
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The analyst wrote that academic research in the US suggested that, under certain conditions in the stomach, ranitidine could form a potentially dangerous compound.
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William Lijinsky was working as a cancer researcher for the US government in 1969 when he determined that nitrosamines could form in the stomach. Nitrites, a common chemical found in cured and grilled meat and in beer and coffee and vegetables, could combine with another group of chemicals called amines, compounds found in many medications. Acid in the stomach created the ideal environment for the reaction. The amount of nitrosamine created at one time might be insubstantial but over time could be dangerous. Lijinsky published studies about nitrosamines. He testified before Congress. He thought the easiest way to minimize the problem was to limit how much sodium nitrite food manufacturers could add to preserve and flavor meat. Ham, bacon, pastrami, corned beef, sausage: foods that, it turns out, are common causes of heartburn and acid reflux.
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They caused cancer in every species of animal tested. A single dose of less than a milligram of NDMA can mutate mice cells and stimulate tumors, and 2 grams can kill a person in days.
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It was first linked to cancer in 1956
It was first linked to cancer in 1956 and is most toxic to the liver. It’s one of a group of chemicals called nitrosamines, which by the 1970s were considered the most potent carcinogens yet discovered.
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NDMA, which is short for N-Nitrosodimethylamine
NDMA, which is short for N-Nitrosodimethylamine, is a yellow liquid that dissolves in water. It doesn’t have an odor or much of a taste.
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