Lawsuits claim that Ranitidine (Zantac) Products are a Leading Cause of Breast, Bladder, Stomach & Other Cancers

The Zantac lawsuits claim that Zantac can be contaminated with the cancer-causing substance N-nitrosodimethylamine (NDMA).

On September 13, 2019, the U.S. Food and Drug Administration (FDA) reported the discovery of the carcinogenic contaminant N-nitrosodimethylamine (NDMA) in Zantac (ranitidine), a common heartburn medication available in both prescription and over-the-counter versions.

In April of 2020, the FDA announced that all Zantac brand heartburn drugs, prescription and over-the-counter, should be immediately pulled from the market because of potential NDMA contamination.

The first Zantac lawsuit was filed in California on 2019. In that lawsuit, the plaintiffs accuse drugmakers Sanofi and Boerhringer Ingelheim of manufacturing, marketing, and selling a product they knew or should have known had been contaminated with an industrial chemical known to cause cancer.

The exact cause of the NDMA contamination is still under investigation. However, during the period in which Boerhinger Ingelheim and Sanofi manufactured and marketed Zantac, scientific research demonstrated a clear link between ranitidine, the active ingredient in Zantac, and NDMA. Specifically, when ranitidine comes in contact with water, it creates a chemical reaction that causes the formation of NDMA.

Despite the availability of this information, the drugmakers chose not to disclose this risk to the government or to consumers.

In addition to causing cancer, NDMA is a potent hepatotoxin. Short-term exposure to NDMA can cause liver damage (such as liver fibrosis and scarring). Long-term exposure can increase the risk of liver, kidney, and lung tumors.Symptoms of NDMA overexposure include headaches; fever; nausea; jaundice; vomiting; abdominal cramps; enlarged liver; reduced function of the liver, kidneys and lungs; and dizziness.

Other adverse effects that have been associated with Zantac include:

  • Nervous System disorders
  • Arrhythmia or Tachycardia (irregular or rapid heartbeat)
  • Vitamin B-12 Deficiency
  • Hepatitis, Liver Failure and Jaundice
  • Increased Risk of Pneumonia
  • Low Platelet Levels in the Blood
  • Skin Rashes and Hair Loss

NDMA is used in aviation and rocket fuel and industrial lubricants. It is also a by-product of several industrial processes, including gasoline refining and the treatment of wastewater containing nitrogen.Other applications for NDMA include inducing carcinogenesis in laboratory rats for cancer research. NDMA may also be found in a number of food products, such as cured meats, and is an ingredient in tobacco fumes. Fortunately, NDMA does not appear to accumulate in tissues.

Under the federal Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA), NDMA is classified as "extremely hazardous." Because of this, there are stringent reporting requirements for companies and individuals who produce, store, or use the substance in large amounts.

The FDA has requested that all manufacturers immediately withdraw prescription and over-the-counter (OTC) ranitidine drugs due to excess levels of NDMA, a probable carcinogen created in the drug. Following the recalls of its brand name Zantac in late 2019, the FDA undertook additional testing which confirms that NDMA levels increase in ranitidine even under normal storage conditions and significantly increases NDMA in ranitidine when stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers. The testing also shows that the older the ranitidine product is, or the longer the length of time since it was manufactured, the higher the levels of NDMA.

The FDA is advising consumers taking ranitidine to contact their healthcare provider to determine an alternative medication. These products will no longer be available for new or existing prescriptions or OTC in the United States.

The Law Firm of Hill, Peterson, Carper, Bee & Deitzler is investigating cases on behalf of individuals who took Zantac and were thereafter diagnosed with cancer. Our firm will work to hold these manufacturers accountable.