FDA Asks Drugmakers To Conduct Their Own Tests Of Heartburn Drug Zantac For Carcinogen, While Walmart Joins In Pulling Drug From Shelves
The FDA is challenging how the test was conducted that showed unsafe levels of a carcinogen, but in the meantime, Walmart has joined other major drug retailers no longer selling the drug.
Stat:
FDA Challenges Testing Used By Lab That Found A Carcinogen In Zantac
As concerns mount over a possible carcinogen found in popular heartburn medicines, the Food and Drug Administration noted that an outside laboratory that discovered traces of the contaminant used a method “not suitable” for testing. As a result, the agency is suggesting the lab may have generated higher levels of the carcinogen than what might have been found otherwise. In a brief statement, the FDA contended that Valisure, which alerted agency officials to the presence of NDMA in heartburn pills such as Zantac, used higher temperatures in its testing than methods used by the agency. (Silverman, 10/2)
Bloomberg:
Zantac Sales Suspended At Walmart, Joins CVS, Walgreens, Rite Aid
Walmart Inc. plans to suspend the sale of all over-the-counter versions of Zantac, becoming the latest retailer to take such a step as concern over the presence of cancer-causing contaminants in the stomach drug increases. The world’s largest retailer said in a statement on Wednesday that it made the move after closely monitoring a recent alert from the U.S. Food and Drug Administration that the products, which are also sold under the generic name ranitidine, may contain low levels of the potential human carcinogen NDMA. (Annett, 10/2)
The Hill:
Walmart Pulls Zantac From Shelves, Joining CVS, Walgreens
Walmart joins CVS Health, Walgreens and Rite Aid in announcing it will no longer sell the drug. Sanofi, the company that makes Zantac, said that the FDA has found that the amounts of the carcinogen in its drug “barely exceed amounts found in common foods.” “We are working closely with the FDA and are conducting our own robust investigations to ensure we continue to meet the highest quality safety and quality standards,” the company said. (Axelrod, 10/2)
