Pharmacies Pull Zantac Over Concern That Contaminant Poses Cancer Risk

Major U.S. pharmacies have pulled Zantac and its generic equivalent off the shelves after concern about a contaminant that poses a small cancer risk.

MARY LOUISE KELLY, HOST:

If you take Zantac, or its generic equivalent for heartburn, it's time to consider other options. In recent days, major drugstore chains have pulled these products from the shelves. The concern is a contaminant that can increase the risk of cancer. NPR science correspondent Richard Harris reports.

RICHARD HARRIS, BYLINE: This problem came to light in June when an online pharmacy that conducts its own quality testing came across a problem with ranitidine, better known by the brand name Zantac. Valisure founder and CEO David Light says the company had recently started doing safety tests for drugs, and one of his colleagues suggested that they look at ranitidine.

DAVID LIGHT: His infant daughter was prescribed ranitidine, the syrup form that is given to infants. And so that was one of the first drugs that we tested.

HARRIS: The results were a shock.

LIGHT: We found dramatically high amounts of NDMA.

HARRIS: That's considered a probable carcinogen and is found in various food products. But in the drug, it was in concentrations that exceeded federal safety standards. At first, they suspected this was a contaminant from manufacturing, but Light says NDMA - that's N as in Nancy - NDMA might actually show up after the drug has left the factory.

LIGHT: Our tests in lab conditions seem to pretty clearly show that the drug is able to degrade into NDMA by itself either in the tablet or actually in the human body.

HARRIS: If that's indeed what's going on here, it might be an inherent property of the drug. That would be bad news for the companies that manufacture those drugs, but it's not a problem for consumers.

MIKE CAROME: In the case of ranitidine, it is not an essential lifesaving medicine for which there are no available alternatives.

HARRIS: Mike Carome at Public Citizen's Health Research Group says there are many other choices, and that's left him wondering why the Food and Drug Administration hasn't acted swiftly. France and Canada, among other countries, have taken stronger actions. And in the past few days, so have some of the major pharmacy chains in this country by pulling ranitidine products from the shelves.

CAROME: They've taken an appropriate public health action. I think they're trying to build trust with their customers and retain that trust in contrast to how the FDA has approached this.

HARRIS: The FDA tells NPR it has run its own tests and validated the findings from the online pharmacy. The agency says it's also asking drugmakers to run their own tests and to send samples to the FDA.

Richard Harris, NPR News.

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