A Drug Contaminant That's Hard to Catch

Nitrosamines that have been linked to cancer could cost Big Pharma billions of dollars

- By Anna Edney

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.

“What’s troubling is the number of drugs where this is showing up,” says Michael Carome, director of the health research group at consumer advocacy group Public Citizen. “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.”