When federal regulators announced the market-wide removal of the heartburn drug Zantac over concerns that it produces a probable cancer-causing impurity, it sent a ripple of worry across the country.
About 15 million of the 60 million Americans who suffer from heartburn take a prescription version of Zantac, and countless others use over-the-counter versions of the medicine on a regular basis. Could they be at an increased risk of cancer?
Zantac contains the active drug ingredient ranitidine, which researchers from independent pharmacy Valisure discovered in September contained N-Nitrosodimethylamine, or NDMA, a substance commonly found in low levels in food and water. Ingesting NDMA in low levels isn’t thought to increase the risk of cancer. But, according to the Food and Drug Administration (FDA) in an April 1 safety communication urging the removal of Zantac from the market, “sustained higher levels of exposure may increase the risk of cancer in humans.”
What prompted the FDA to request the removal of Zantac was new testing by the agency and evaluation of information from third-party laboratories that confirmed that NDMA levels increase in ranitidine even under normal storage conditions. Likewise, the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. As a result, levels of NDMA in Zantac could rise well above acceptable daily intake limits, and put consumers at risk.
NDMA has been found “in laboratory research to induce tumors in experimental animals,” according to the U.S. National Library of Medicine. Some cancers that may be related to NDMA include stomach, small intestine, bladder, kidney, colorectal, esophageal, prostate, pancreatic, leukemia, non-Hodgkin’s lymphoma, and multiple myeloma. At this point, no studies have been published that can identify how great the risk of developing cancer is for someone who has used these drugs, or the specific tumors it may cause. Nonetheless, the news is unsettling.
Sanofi, makers of brand-name Zantac, was aware for months that its heartburn medication contained NDMA. The company’s preliminary recall in October is proof that its own test results were, at the very least, alarming.
Dozens of consumers are holding Sanofi and makers of ranitidine accountable, and have filed lawsuits against Big Pharma for putting profits ahead of patients. Beasley Allen attorneys Frank Woodson and Lisa Courson are actively investigating potential claims involving regular Zantac/ranitidine use that may have led to cancer of the stomach, colon, intestines, kidneys, bladder or pancreas. If you or a loved one may have been affected, please contact us.