Regulators review safety of popular heartburn drugs like Zantac

Global health regulators sounded a coordinated alarm about the possibility that a stomach drug taken by millions of people around the world could be tainted with the same cancer-causing agent that has sparked a worldwideDrug-safety officials in the US and Europe said on Friday that they were looking into whether Sanofi heartburn medication Zantac and generic versions made by numerous manufacturers contain levels of the probable carcinogen NDMA that could pose a danger to patients.

The discovery further underscores the challenge pharmaceutical-industry regulators face in overseeing a vast global supply chain of drugs, drug ingredients and factory processes. Dozens of versions of the hypertension treatment valsartan have been recalled since last year out of concern they could be contaminated with NDMA.Many of those drugs were made in China or India, raising questions about the quality of generic manufacturing in far-flung factories around the globe.

The FDA detected NDMA in both prescription and over-the-counter versions of Zantac but hasn't collected enough samples to give a range of carcinogen levels found, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said in an interview. FDA and European regulators use different testing methods than Valisure, she said, but declined to give details.

Once international regulators agree on NDMA testing methods for the drugs, the agency will ask manufacturers to test their versions of Zantac, Woodcock said. The agency will also seek samples from manufacturers to test itself and expects it will take a couple weeks to get more information, Woodcock said.

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