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A New Contaminant Found in Popular Drugs Could Cost Big Pharma Millions

Nitrosamines, linked to cancer, have surfaced in Zantac, Januvia, and generic valsartan. Now lawyers are circling.
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Illustration: Daniel Zender for Bloomberg Businessweek

When a drug is recalled because there’s something in it that shouldn’t be, it’s scary but often traceable: Foreign objects such as shards of metal or microorganisms might infiltrate medications through dirty factories or lax manufacturing practices. But recently a more insidious—and difficult to eradicate—form of contamination has surfaced among makers of some of the world’s best-selling pharmaceuticals. They’re called nitrosamines.

Rather than poisoning drugs through unsanitary conditions, nitrosamines—a group of organic compounds that animal studies have linked to cancer—stem from chemical interactions that are only now becoming understood and have proven complicated to fully avoid. That complexity could cost Big Pharma big time. A recent report from Morgan Stanley says trial judgments over nitrosamines against the makers of Zantac, including GSK and Sanofi, could reach $45 billion alone. But other big companies such as Merck and Pfizer have also found nitrosamines in their drugs, and the Zantac trials could turn attention on them.