High levels of NDMA reportedly found in Zantac samples

Carcinogen in Heartburn Drug May Build in Storage, Lab Finds

News reports the heartburn medicine Zantac (ranitidine) “appears to produce unacceptably high levels of a cancer-causing chemical when exposed to heat for as little as five days, according to a testing laboratory that’s urging the U.S. Food and Drug Administration to recall all forms of the widely used product.” Since at least September, the FDA “has been monitoring the presence of” a toxic chemical called NDMA that has been “found in some samples of Zantac, which is also sold in generic versions.” New testing “by an Alameda, California-based independent laboratory called Emery Pharma found that a combination of heat and time can raise levels of NDMA, potentially while drugs are sitting in packaging well after being analyzed by their manufacturers.”

Numerous manufacturers have already pulled products from pharmacy shelves, including Sanofi, which makes the brand-name version of Zantac. A leading oncology hospital, New York’s Memorial Sloan Kettering Cancer Center, has also said it will no longer offer the drug to patients while it reviews the risk. The FDA has yet to push for any widespread recall.

The FDA has been investigating whether ranitidine, the active ingredient in Zantac, is converted into NDMA inside the body after it’s been consumed. The agency said its tests have shown levels in the medicine that are naturally found in smoked and grilled meats. While manufacturers conduct stability tests on new medicines in development, Zantac was originally approved in 1983, well before the technology existed to pick up such low levels of NDMA, Najafi said.

Our law firm is looking into Zantac cases at this time and their possible recall as a Mass Tort action. Call today for a free consultation.



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