Liver cancer rates are on the rise. According to the American Cancer Society (ACS), about 42,810 people will be diagnosed with liver cancer in 2020, and about 30,000 will die from it. Incidence rates have more than tripled since 1980, while death rates have more than doubled.

Thousands of consumers who took the heartburn medication Zantac and its generic equivalents (ranitidine) are now worried about liver cancer. In September 2019, the U.S. Food and Drug Administration (FDA) warned that a cancer-causing agent had been discovered in samples of the medication. So far, the agency has not been able to determine how long the medication may have been affected.

Manufacturers are responsible for ensuring their medications are safe for public use before releasing them on the market. Unfortunately, Zantac manufacturers failed to make sure that their products were free of carcinogens, which has put public health at risk.

Chaffin Luhana is currently investigating cases in which patients took Zantac or generic forms of ranitidine and then suffered serious injuries and/or liver cancer.

What is Liver Cancer?

Liver cancer is a type of cancer that begins in the liver, which is the largest internal organ in the body. It’s located just under the ribs on the right side, underneath the right lung. It’s such a critical organ that human beings can’t live without it. Every day, the liver:

• breaks down and stores many of the nutrients absorbed from the intestine
• makes the clotting factors that help stop bleeding when necessary
• breaks down alcohol, drugs, and toxic wastes in the blood so they can be flushed out with other waste materials
• delivers bile into the intestines to help absorb nutrients

Several different types of cancer may form in the liver. The most common is called hepatocellular carcinoma, and it affects the main liver cells, called hepatocytes. Other types of liver cancer are less common.

Like many other types of cancer, liver cancer doesn’t cause any symptoms in its early stages. As it grows, the following symptoms may occur:

• Loss of appetite
• Unintentional weight loss
• Nausea and vomiting
• Unexplained weakness
• Upper abdominal pain
• Abdominal swelling
• Jaundice (yellowing of the skin and eyes)
• White, chalky stools

The following factors may increase your risk of developing liver cancer:

• Nonalcoholic fatty liver disease (more common with the obesity epidemic)
• Cirrhosis
• Inherited liver diseases
• Diabetes
• Excessive alcohol consumption
• Chronic infection with hepatitis B or hepatitis C
• Exposure to aflatoxins (poisons produced by molds that grow on crops)

Treatments for liver cancer depend on how far it has advanced and on the person’s overall health. They include surgery to remove any tumors, localized treatments that kill cancer cells (such as cryoablation or radiofrequency ablation), radiation therapy, chemotherapy, targeted drug therapy, and immunotherapy. As a last resort, a liver transplant may be needed.

The 5-year survival rate for liver cancer depends on whether it is detected while it is still localized in the liver, or after it has spread to other organs. Localized cases have a 33 percent 5-year survival rate. Once the disease has spread, the survival rates drop.

What is NDMA?

NDMA is a semi-volatile organic chemical that belongs to a class of chemicals called “nitrosamines.” It is not currently produced for any use in the United States except as a research chemical, but it can form in both industrial and natural processes when certain chemicals come together and react.

Common industrial sources of NDMA include amine manufacturing plants, tanneries, pesticide manufacturing plants, rubber and tire manufacturing, fish processing facilities, foundries, dye manufacturers, and surfactant industries. It can also be an unintended byproduct of the chlorination of wastewater and drinking water at treatment plants that use chloramines for disinfection.

NDMA may also be found in certain types of foods, particularly cured meats like bacon and hot dogs. Chemicals called nitrites or nitrates are often added to these foods to extend shelf-life, prevent the growth of bacteria, and preserve texture and flavor. These chemicals can then react with the amines in meat during processing, storage, and cooking (particularly frying) to form nitrosamines like NDMA. In fact, studies show that NDMA is the most frequently occurring nitrosamine in foods.

According to the World Health Organization (WHO), levels of NDMA in food have decreased in recent years because of changes in food processing, but it can still be found in processed meats and fried foods. The agency adds that based on laboratory studies, “NDMA is clearly carcinogenic…potentially at relatively low levels of exposure.”

The International Agency for Research on Cancer (IARC) has also qualified NDMA as a probable human carcinogen, as has the U.S. Environmental Protection Agency (EPA) and the U.S. Department of Health and Human Services (DHHS).

The key is to limit your exposure as much as possible. Low levels of exposure are less likely to increase the risk of cancer than high levels are.

NDMA Linked with Liver Cancer

The CDC notes in its public health statement that “NDMA is very harmful to the liver of animals and humans.” People who were intentionally poisoned by unknown levels of NDMA in beverages or foods died of severe liver damage with internal bleeding. Animals exposed to high levels of the chemical for days or several weeks also developed serious, non-cancerous liver disease. 

When animals ate food, drank water, or breathed air containing lower levels of NDMA for periods longer than several weeks, they suffered from liver cancer as well as non-cancerous liver damage. In one study on animals exposed to NDMA, researchers found that even at low dose rates, liver damage occurred. Indeed, researchers are now known to use NDMA specifically to induce liver toxicity in animal studies.

So far, outside of poisoning incidences, we don’t have human studies examining the relationship between NDMA and liver cancer. There has been some limited research on the intake of nitrosamines in the diet, however, and liver cancer.

In a 1999 study, for instance, researchers looked into incidences of liver cancer in Thailand. They noted there was a high incidence of the disease there and it was not associated with common factors like hepatitis infections or excessive alcohol consumption.

The looked into the diet and environment in areas where liver cancer rates were high and ended up testing over 1800 samples of fresh and preserved food, analyzing them for nitrosamines. They found relatively high levels of NDMA and other nitrosamines in the fermented fish the people ate, as well as in several salted and dried fish, fermented beans, and other vegetables. They concluded that nitrosamines in Thai food could be a possible cause of the high rates of liver cancer.

NDMA Discovered in Zantac and Generic Ranitidine

Zantac was first approved in 1983 as a prescription drug. It belongs to a class of medications called histamine H2-receptor agonists (H2 blockers) which all decrease the amount of acid produced in the stomach. These medications are used to treat gastric ulcers, heartburn, acid indigestion, sour stomach, and other gastrointestinal conditions.

Zantac became available over-the-counter in 1996 and has since been used by millions of people to solve their digestive problems. Believing it was safe to ingest, thousands of people used the drug on a regular, sometimes daily, basis.

Then in June 2019 something happened. Online pharmacy Valisure technicians were testing a few samples of Zantac—part of their regular testing of products sold—when they discovered that all of the medicines contained NDMA. They immediately notified the FDA of their findings and continued their investigation.

On September 9, 2013, Valisure sent a citizen’s petition to the FDA, warning them that the medication was not safe, and encouraging the agency to recall all forms of ranitidine on the market. Company executives were particularly concerned because according to their research, the NDMA was not the result of a manufacturing problem or rare contamination. Instead, it seemed to be the result of the instability of the ranitidine molecule itself, which could break down during human digestion to form NDMA.

Authors David Light, CEO, and Kaury Kucera, Chief Scientific Officer, wrote in their petition: “Valisure’s tests suggest ranitidine can react with itself,” adding that the ranitidine molecule “contains both a nitrite and a dimethylamine (‘DMA’) group which are well known to combine to form NDMA.”

To support this argument, Valisure pointed to a 2016 study conducted at Stanford University in which researchers gave participants ranitidine and measured the NDMA found in urine samples 24 hours later. The results showed that NDMA increased 400-fold from 110 to 47,600 nanograms (ng) after ranitidine intake, while total N-nitrosamine increased 5-fold. (The FDA upper limit for NDMA is 96 ng.)

The FDA notified the public that NDMA had been discovered in Zantac and generic ranitidine, but stopped short of recommending consumers stop using the product, stating that the levels of NDMA discovered “barely exceed amounts you might expect to find in common foods.”

The FDA did suggest that ranitidine manufacturers test their products. Many companies did so, and they also found NDMA. Several product recalls followed, with Zantac manufacturer Sanofi recalling Zantac in October 2019.

The FDA does not agree with Valisure that Zantac and generic ranitidine may form NDMA during digestion. In a statement dated November 2019, FDA Director for the Center for Drug Evaluation and Research Janet Woodcock, M.D. wrote that FDA tests simulating ranitidine digestion in the human stomach indicated that NDMA was not formed through this process. Woodcock added that “we still must test the drugs in the human body to fully understand if ranitidine forms NDMA.”

To date, the FDA maintains that determining the source of NDMA in ranitidine is “an ongoing investigation.”

FDA Recalls All Ranitidine from the Market

Though many companies recalled their ranitidine products in the latter part of 2019, the FDA did not require an overall recall of the medication until April 1, 2020. It was the results from an independent lab that finally encouraged the FDA to take this final action.

Independent laboratory Emery Pharma found during its tests on ranitidine that while stable at room temperature, the molecule could become unstable under elevated temperatures of about 158 degrees Fahrenheit, producing NDMA.

In a citizen’s petition Emery sent to the FDA, President and CEO Ramin Najafi, Ph.D. wrote, “This was concerning since significantly elevated temperatures can occur within closed vehicles during transportation and during storage of the drug, because there is no requirement for ranitidine to be cold-chained, i.e., shipped in temperature-controlled conditions and stored under refrigeration.”

Additional tests showed that NDMA also increased with time—the older the ranitidine product is, the greater the level of NDMA.

Based on these findings, the FDA determined that the benefits of the drug no longer outweighed the risk, and recalled it. Consumers were advised to stop taking ranitidine products and seek other treatment alternatives.

Types of Injuries Associated with Zantac (Ranitidine)

Considering the potential exposure to NDMA, the following injuries may be associated with long-term intake of Zantac and generic ranitidine:

• Bladder cancer
• Stomach or gastric cancer
• Intestinal cancer
• Kidney cancer
• Liver cancer
• Esophageal cancer
• Pancreatic cancer
• Prostate cancer
• Breast cancer
• Testicular cancer
• Colorectal cancer (colon or rectal cancer)
• Uterine (endometrial) cancer
• Death

Zantac Liver Cancer Lawsuits

If you took Zantac for an extended period, you may not be understandably concerned about your potential risk for cancer, including liver cancer.

Others who are similarly concerned have already filed Zantac lawsuits in courts around the country. They claim that the manufacturers should have known that their products contained a cancer-causing agent, and should have either provided adequate warnings to the public about the risks or should have taken steps to resolve the issue.

Indeed, there was evidence early on that ranitidine could be toxic, and even evidence that it could form NDMA. In a 2011 study, for instance, researchers found that out of eight pharmaceuticals observed, “ranitidine showed the strongest potential to form N-nitrosodimethylamine (NDMA)” when present in drinking water during chloramine disinfection. The researchers added that the drug gave a much higher yield of NDMA than reported in prior studies.

On February 6, 2020, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federally filed Zantac lawsuits into the Southern District of Florida. District Judge Robin L. Rosenberg was appointed to oversee the proceedings.

If you took Zantac or ranitidine regularly and were later diagnosed with liver or other forms of cancer, you may be eligible to file a Zantac lawsuit to recover damages. Chaffin Luhana is now investigating these cases and invites you to call today at 888-480-1123.