Zantac Lawsuits

In 2019, the U.S. Food and Drug Administration (FDA) reported the discovery of the carcinogenic contaminant N-nitrosodimethylamine (NDMA) in Zantac (ranitidine). In April 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, a chemical linked to cancer.

The first Zantac lawsuit was filed in 2019 – 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. 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.

Complications and Symptoms

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), and 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
• 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

NDMA applications:

• aviation and rocket fuel and industrial lubricants
• by-product of several industrial processes, including gasoline refining and the treatment of wastewater containing nitrogen
• inducing carcinogenesis in laboratory rats for cancer research
• 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.