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How Do You Stop Taking! - Recalled Medication

Bloomberg Businessweek

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December 16, 2019

IF YOU DON'T KNOW IT'S BEEN RECALLED?

- Margaret Newkirk And Susan Berfield

How Do You Stop Taking! - Recalled Medication

IN MID- SEPTEMBER the U.S. Food and Drug Administration received a 19-page document with some startling claims about a popular medicine. The online pharmacy Valisure, which tests prescription drugs before dispensing them, said it had found extremely high levels of a probable human carcinogen in the antacid ranitidine, best known under the brand name Zantac. Millions of people around the world use ranitidine; it’s available both with a prescription and over the counter. As for the carcinogen, NDMA, the FDA knew it well: For more than a year the agency had been recalling batches of the blood pressure medication valsartan because they were contaminated with it.

The FDA issued an alert, one that seemed to downplay Valisure’s findings. The agency said it had learned that some ranitidine medicines contained low levels of NDMA, but it wasn’t advising people to stop taking the drug. Those with prescriptions could contact their doctors—if they were worried— and everyone else could consider alternatives on drugstore shelves. In fact, Valisure had found high levels of NDMA in every version of ranitidine it tested and concluded the problem was inherent to the molecule itself. In other words, if Valisure is correct, there is no safe version of ranitidine.

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