Scientific studies have connected exposure to NDMA with an increased risk of colorectal cancer

By Shaniqua Williams

Posted on March 10th, 2020

The possible contamination of Ranitidine products with NDMA is a worry but the significantly more serious concern is Ranitidine's potential to form millions of nanograms of NDMA in the human body. Studies have demonstrated a strong link between consuming excessive amounts of NDMA and colorectal cancer.

If you previously relied on Zantac or generic Ranitidine to prevent and relieve heartburn or acid reflux, you likely noticed that the product disappeared from stores since September 2019. This is because the U.S. Food and Drug Administration reported levels of the probable carcinogen N-nitrosodimethylamine (NDMA) above the acceptable daily intake limit - 96 nanograms per day.

N-nitrosodimethylamine (NDMA) and other volatile N-nitroso compounds are potent carcinogens that can induce tumors in almost every organ in rodents, the organ specificity often varying with the chemical structure of the compound. Today, human exposure to these compounds can occur through absorption from the environment, dietary consumption, as well as from endogenous synthesis within the body.

Classified as a probable human carcinogen based on evidence from laboratory and human research studies

Ranitidine metabolizes into N-nitrosodimethylamine which is recognized by reputable health agencies as a cancer-causing agent:

  • The US Environmental Protection Agency (EPA) classifies NDMA as a "confirmed animal carcinogen" and as a B2 carcinogen, meaning it is a "probable human carcinogen";
  • The International Agency for Research on Cancer lists NDMA as highly likely carcinogenic to humans, potentially at relatively low levels of exposure;
  • The U.S. Department of Health and Human Services has identified NDMA in Ranitidine and stated that the organic chemical is "reasonably anticipated" to be a human carcinogen;
  • The State of California says that NDMA is among the chemicals known to the state to cause cancer, and cites the National Toxicology Program as recognizing them as "reasonably anticipated to be human carcinogens";
  • Scientists sometimes use NDMA to induce tumors in laboratory animals on purpose, for research.

Cancer-causing agents found in over-the-counter and prescription Ranitidine products are leading to a number of health-related issues, including colorectal cancer. Ranitidine, belongs to a group of drugs called histamine-2 blockers and has a molecular structure that makes it susceptible to naturally creating NDMA once ingested.

More precisely, the Ranitidine compound contains the two elements that are required to form NDMA: nitrite and dimethylamine. The presence of both nitrite and dimethylamine in Ranitidine's chemical structure renders it highly capable of producing NDMA in the digestive tract.

Zantac and generic ranitidine medications found to contain high levels of NDMA chemical known to increase the risk of colorectal cancer

Studies have been conducted specifically to investigate the hypothesis that intake of NDMA increases the risk of colorectal cancer. A compelling amount of research has demonstrated that N-nitrosodimethylamine plays an important role in colorectal carcinogenesis through the induction of DNA-damaging metabolites, which could consequently lead to cancerous lesions in cells.

In a more recent study, researchers examined the association between exogenous intake of N-nitroso compounds and colorectal cancer, in over 1,700 patients. Results showed that the intake of NDMA can be associated with an increased risk of cancer, specifically rectal cancer.

Colorectal cancer, also known as bowel cancer, colon cancer, or rectal cancer is a malignant tumor arising from the inner wall of the large intestine or rectum. Because many patients with colorectal cancer do not have any symptoms until the disease is advanced, regular screening is the key to find precancerous polyps so that they can be removed before they turn into cancer. Early warning signs of colorectal cancer may include:

  • Abdominal pain
  • Constipation or diarrhea
  • Loose, narrow stools
  • Changes in stool color
  • Blood in the stool
  • Bleeding from the rectum
  • Iron-deficiency anemia

About 200,000 Americans are diagnosed with colon cancer every year. Colon cancer is highly treatable, particularly when discovered in its earliest stages.

The symptoms and signs of colorectal cancer listed above are the same as those of extremely common conditions that are not cancer, such as inflammatory bowel diseases such as irritable bowel syndrome, diverticulitis, and colitis. If you are concerned about your risk for cancer after taking Zantac, contact your prescribing physician immediately. Based on your current health status and available treatment alternatives, your doctor will provide you with a recommended course of action that is personalized to meet your medical needs.

Did drug makers know of the risk for high NDMA levels in their products and yet neglected to disclose this risk to the public?

Exposure to the carcinogen NDMA produced by Zantac resulted in colon cancer, according to a man who took a daily dose of 300 mg Zantac for eight years. The complaint was filed in the U.S. District Court for the Southern District of California, alleging that drug makers knew that Ranitidine metabolizes into unsafe levels of NDMA when exposed to stomach conditions but failed to properly warn the public either by properly labeling the drug or through any other means such as in the product monograph.

We have extensive experience in building a strong case for a favorable outcome

If you have been taking Zantac, it is helpful to consult your regular physician or another trusted medical professional to determine the individual health risk you could face.

If you have been diagnosed with colorectal cancer after regularly taking Zantac, we can review the specifics of your case and advise you of your legal options so you can make a well-informed decision with your family's financial future in mind. Attorneys at Environmental Litigation Group, P.C. can effectively represent your interests in seeking financial compensation for the direct harm caused by Zantac's effects on your health.