In the latest step of a major investigation, the U.S. Food and Drug Administration has determined that prescription and over-the-counter (OTC) ranitidine medications, including Zantac, may expose consumers to “unacceptable levels of impurity.” As a result, the FDA is requesting that manufacturers withdraw all ranitidine products from the market immediately and is advising consumers to stop taking the drug.
Since the summer of last year, the agency has been investigating the drug’s connection to a contaminant called N-Nitrosodimethylamine (NDMA), a probable human carcinogen that may be linked to cancer in those who consume it.
The FDA has now determined Zantac and generic equivalents could become contaminated with NDMA even more easily than previously suspected. Whereas initial testing found that NDMA levels can increase in ranitidine when exposed to heat, new testing shows that the amount NDMA can increase to a dangerous level even under normal storage conditions and temperatures. The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the more NDMA it is likely to contain.
Per the FDA’s request for removal of ranitidine products, the drug will not be available for new or existing prescriptions or OTC use in the U.S. Consumers who take Zantac or another ranitidine drug are advised to stop use and find an alternative treatment if necessary. Those taking OTC ranitidine should consult their physician or pharmacist about using other approved products. For patients taking prescription ranitidine, the FDA advises they speak with their health care provider as soon as possible about other treatment options before suspending use of the medication.
The FDA also advises consumers to properly dispose of any ranitidine products they possess after acquiring an alternative medication. In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location, and instead safely dispose of it in the garbage or follow the specific disposal instructions in the medication guide or package insert.
At Saunders & Walker, we urge that if you are taking Zantac or a generic equivalent to please consult your healthcare provider to determine if you should switch to an alternative medication.
Since the FDA’s initial warning about Zantac and other ranitidine drugs last September, hundreds of lawsuits related to cancer diagnoses have been filed against drug makers. The growing number of cases has led to a consolidation known as a multidistrict litigation, or MDL, which is a streamlining procedure that allows potentially thousands of additional Zantac-related lawsuits to also join the litigation.
Saunders & Walker is diligently monitoring this situation as more information is released and has already filed lawsuits for affected individuals. We predict the number of cases will continue to increase, considering ranitidine has been widely available since 1983 and an estimated 15 million Americans are currently prescribed it.
If you or someone you love has taken Zantac and has had a diagnosis of a primary cancer of the digestive tract, such as small intestine, colorectal, esophageal, liver, bladder, and pancreatic cancers, or if you have a blood related cancer such as leukemia, non-Hodgkin’s lymphoma, or multiple myeloma, you should seek legal counsel as soon as possible. The diagnosis could be linked to ranitidine, and you or your loved one could be entitled to financial compensation.
Please contact Saunders & Walker at 1-800-748-7115 a free information to learn about case eligibility.
Admitted to practice law in all federal multidistrict litigation courts, the California State Bar and the Florida Bar. His philosophy is to provide aggressive, quality representations and seek fair compensation for individuals and their families who have suffered injury, death, or sexual abuse.