The U.S. Food and Drug Administration (FDA) announced yesterday that it is requesting that manufacturers withdraw all prescription (Rx) and over-the-counter (OTC) ranitidine drugs (commonly known by the brand name Zantac) from the market immediately. This is the latest move in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications. The FDA has determined that this impurity in some ranitidine products increases over time, and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.
NDMA is considered a probable human carcinogen (a substance that could cause cancer). In the summer of 2019, the FDA became aware of independent laboratory testing that found NDMA in ranitidine. Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans. New FDA testing and evaluation have confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers. The testing also showed that the older a ranitidine product is, 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-in some instances up to 3000 times the accepted safe limit.
If you took the popular heartburn medication Zantac for a year or more, and you developed a cancer of the digestive tract, including cancer of the esophagus, stomach, liver, kidney, bladder, colon, pancreas, or prostate, you may have a case. To protect your right to compensation, you must not delay, or you may miss the statute of limitations (deadline) for your case. Our attorneys are here and ready to help. Call us today at 336-814-2126.