The U.S. Food and Drug Administration is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. The request follows the discovery that these products could contain a probable human carcinogen called N-Nitrosodimethylamine (NDMA), and could therefore be linked to cancer in those who take it.
This request for removal is the latest step in an ongoing investigation of ranitidine medications, commonly known by the brand name Zantac.
The FDA first became aware of possible issues with the drug in summer 2019, when independent laboratory testing found NDMA in ranitidine. The FDA first issued a warning to the public last September, stating it had “learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.”
The organization called for drug manufacturers to test their products for the impurity, and many pharmacies quickly pulled the drugs from their shelves. Then, in February of this year, an independent laboratory in California called Emery Pharma confirmed the drug could be even more dangerous than suspected. Emery Pharma filed a petition with the FDA, claiming their research showed Zantac and generic equivalents produce high levels of cancer-causing NDMA when exposed to heat for as little as five days, such as during shipping or warehousing. Further research showed those levels could rise while the drugs are sitting in their packaging waiting to be distributed, or even after being received by the consumer.
Now, new FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels can increase in ranitidine even under normal storage conditions. 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 most recent discoveries mean ranitidine products can become dangerous to the consumer even more easily than previous thought. The FDA has subsequently determined that taking some ranitidine medications, including Zantac, may expose consumers to “unacceptable levels of this impurity,” according to its most recent statement.
The FDA is now sending letters to all manufacturers of ranitidine requesting they immediately withdraw their products from the market. As a result, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.
The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more.
At Saunders & Walker, we urge that if you are taking Zantac or a generic equivalent to please consult your physician or pharmacist to determine if you should switch to an alternative medication.
Since the FDA’s initial warning about Zantac and other ranitidine drugs, 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 predicts this number of cases will continue to increase, considering the product has been widely available since 1983. We are diligently monitoring this situation as more information is released and have already filed a case on behalf of an affected individual.
If you have taken Zantac and 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 – it might be related to Zantac use.
To learn about case eligibility and whether you may be entitled to financial compensation, please contact Saunders & Walker at 1-800-748-7115 for a free consultation.
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.