There has been a widespread recall of Zantac (Ranitidine) and other heartburn drugs due to concerns that they contain the carcinogen N-nitrosodimethlylamine (NDMA).
Why were Heartburn Medications containing Ranitidine Taken off the Market?
In June 2019, the pharmacy company Valisure alerted the US Food and Drug Administration (FDA) that they found concerning levels of a possible carcinogen in Ranitidine during routine testing. Though the FDA has not issued an official recall, they stated in October 2019 that they were ordering all Zantac manufacturers to conduct testing for NDMA. Many of these manufacturers have issued voluntary recalls themselves due to these concerns.
Has there been Scientific Research and Testing done to Confirm there is NDMA Contamination in Zantac (Ranitidine)?
NDMA has been known as a cancer risk for decades and was formerly used in the production of rocket fuel, lubricant additives, and plastics. An article from the 1970s stated that “NDMA has caused cancer in nearly every laboratory animal tested so far.” It is also well documented in scientific literature from as early as the 1980’s that NDMA is formed by the reaction of dimethylamine (DMA) and a “nitroso source” such as nitrate (N).
As it happens, the Ranitidine molecule has both a nitrate group and dimethylamine group on either end and tests have shown it can easily break down and essentially “react with itself” to form NDMA. There are additional studies from the 2000s that show NDMA contamination in drinking water that was processed in wastewater treatment plants. These results were specifically linked to “urinary NDMA excretion” from Ranitidine users.
Valisure, the company that first reported the NDMA contamination, filed an official petition for recall of Ranitidine to the FDA 3 months following their initial report. This first test used FDA protocol and found “exceedingly high levels” in every lot of Ranitidine tested, all had at least 2 million ng of NDMA, significantly higher than the FDA allowable limit of 96 ng. They proceeded to re-test the drug under various conditions - lowering the temperature to more approximate the human body, in both “Simulated Gastric Fluid” and “Simulated Intestinal Fluid’, and adding various concentrations of nitrate (to reflect the ingestion of foods like processed meats as well as the elevated levels of nitrate that naturally occur in the stomach with antacid use). All of these subsequent tests also showed extremely high and unsafe concentrations of NDMA.
These tests demonstrate the presence of the carcinogen NDMA both in Ranitidine and after ingesting Ranitidine. Zantac-users who have developed cancer are filing lawsuits against the manufacturers that produce these drugs on several counts. They state that the drug companies were responsible for testing products and had a duty to report the true “character, quality, and nature” of the drug. One particular case cites that “going back as far as 1981, two years before Zantac entered the market, research showed elevated rates of NDMA” and the Ranitidine manufacturing companies therefore “knew or had reason to know that Zantac products were defective and were inherently dangerous and unsafe when used in the manner instructed and provided”.
Cancer Lawsuits are Currently Being Filed Against the Manufacturers of Zantac (Ranitidine).
How Can We Help?
If you or a loved one has developed cancer after using Zantac (Ranitidine), you aren’t alone - our dedicated attorneys have experience representing clients in mass tort cases. By filing/joining a mass tort claim against Zantac, you may be able to get compensation for your damages and protect others from future threats. Our attorneys will be by your side to help you navigate this complex process with ease.
Don’t hesitate to pursue the compensation you deserve to make up for the pharmaceutical companies’ mistakes. Contact us today to schedule a free consultation and learn your rights.