Beasley Allen lawyers applaud the Food and Drug Administration’s (FDA’s) move to pull the heartburn medicine Zantac and generic drugs containing the ingredient ranitidine off the market. The FDA made the announcement this week, requesting all prescription and over-the-counter versions of the heartburn drug be immediately withdrawn from the market due to the presence of the probable human carcinogen NDMA.
Beasley Allen lawyer Frank Woodson is leading the charge. Frank is actively investigating potential claims involving regular Zantac/ranitidine use that may have led to cancer of the stomach, colon, intestines, kidneys, bladder, or pancreas.
“Makers of Zantac have been aware of the contaminate N-nitrosodimethylamine or NDMA as a possible human carcinogen for years. A preliminary recall of Zantac OTC in the United States and Canada in October is proof that the results were at the very least alarming. The FDA has now called for the product to be pulled from the market because of the link being made between the drug and some cancers, including stomach, small intestine, bladder, kidney, colorectal, esophageal, prostate, pancreatic, leukemia, non-Hodgkin’s lymphoma, and multiple myeloma.”
— Frank Woodson, Managing Attorney, Mobile Office
NDMA In Zantac
NDMA is found in low levels in the environment and is commonly ingested in the diet. Low levels are not considered a cancer risk to humans. However, last year, independent pharmacy Valisure alerted the FDA of testing that revealed NDMA in some ranitidine products. At that time, the agency said that it did not have enough scientific evidence to recommend that consumers stop using it. Prompted by information gathered by third-party laboratories, the FDA conducted new testing and evaluation that revealed more cause for concern.
The new data confirmed that NDMA levels increase in ranitidine even under normal storage conditions and increase significantly in samples stored at higher temperatures, including temperatures the product may have been exposed to during distribution and handling by consumers. The older the ranitidine was, or the longer the length of time since it was manufactured, the greater the level of NDMA. “These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit,” the FDA said.
Previous studies have found that it is also possible that medicines containing ranitidine can cause NDMA to form in the body after ingestion. Approximately 60 million people suffer from heartburn, 15 million use prescription ranitidine, and countless others use over-the-counter versions. Consumers who may have been affected can contact the firm for more information.