In January 2020, an Ohio man filed a Zantac lawsuit in the U.S. District Court for the Northern District of Ohio. After taking Zantac (ranitidine) for 24 years, he was diagnosed with pancreatic cancer and claimed the manufacturers should be held liable.

The plaintiff and others like him seek damages from the makers of Zantac because it has been found to contain unsafe levels of N-nitrosodimethylamine (NDMA), a probable human carcinogen. On April 1, 2020, the U.S. Food and Drug Administration (FDA) requested the removal of all ranitidine medications from the market because of tests indicating the presence of unsafe levels of NDMA.

The American Cancer Society (ACS) estimates that in 2020, about 57,600 adults in the United States will be diagnosed with pancreatic cancer, and about 47,050 will die from it. Pancreatic cancer is the ninth most common cancer in women and the tenth most common in men, while it is the fourth leading cause of cancer death in both men and women.

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

What is Pancreatic Cancer?

The pancreas is a fish-shaped organ that sits in the upper tummy behind the stomach on the right side. It is part of the digestive system, producing about 1.5 to 2 liters per day of enzyme-rich digestive juices that flow into the small intestine to help release nutrients from foods and beverages. The pancreas also produces hormones, including the hormone “insulin” that helps convert the sugar in foods to energy.

Pancreatic cancer is any type of cancer that develops in the pancreas. Several different types of growths can occur there, but the most common begins in the cells that line the ducts carrying digestive enzymes out of the pancreas.

Doctors don’t know what causes pancreatic cancer, but they do know that certain factors can increase the risk it will develop. These include age (over 65), smoking, inherited gene mutations, diabetes, chronic inflammation of the pancreas (pancreatitis), a family history of pancreatic cancer, and obesity.

Like many other types of cancer, pancreatic cancer doesn’t cause any noticeable symptoms until it has become advanced enough to spread to other organs. It’s very difficult to diagnose in its early, most curable stages for this reason. When symptoms finally do appear, they may include:

• Unintended weight loss
• Abdominal pain that radiates to the back
• Light-colored stools
• Dark-colored urine
• Jaundice (yellowing of the skin and eyes)
• Unusual fatigue
• Blood clots
• Itchy skin

Treatment for pancreatic cancer depends on its severity and how far it has spread. Surgery can remove tumors in the pancreas, while chemotherapy and radiation help kill other cancer cells. The ACS states that the overall 5-year survival rate for pancreatic cancer is low—only 9 percent. If it’s diagnosed before it spreads, that rate goes up to 37 percent. As these numbers are based on data from between 2009 and 2015, the rates may be better now, as treatment continues to improve.

What is NDMA?

NDMA is a known environmental contaminant that can be found in soil, air, water, and in a myriad of products we use every day. It’s a chemical belonging to a class of chemicals known as “nitrosamines,” most of which are carcinogenic.

NDMA used to be used to make rocket fuel in the U.S., but after investigators found elevated levels of it in the air, soil, and water surrounding rocket fuel manufacturing plants, companies stopped using it. Today, NDMA is produced only as a research chemical, to be used in laboratory studies to induce cancerous changes.

Even though manufacturers are no longer making NDMA, it can still form as a result of other chemical reactions, particularly reactions involving “alkylamines,” which are both natural and man-made compounds found widely distributed throughout the environment. According to a report on the chemical from the World Health Organization (WHO), NDMA “continues to be released as a by-product and contaminant from various industries and from municipal wastewater treatment plants. Major releases of NDMA have been from the manufacture of pesticides, rubber tires, alkylamines, and dyes.”

NDMA can also form under natural conditions and has been detected in drinking water and automobile exhaust, as well as in certain types of food like beer, cured meat, and fish products, though levels have decreased in recent years because of improvements in food processing.

Still, processed meats today are thought to be a persistent source of nitrosamines like NDMA, because manufacturers add nitrates and nitrites to them to extend shelf life and to preserve flavor and texture. These chemicals can interact with meat under certain conditions—particularly those involving high temperature cooking like frying—to produce nitrosamines.

The World Health Organization (WHO), the International Agency for Research on Cancer (IARC), and the U.S. Environmental Protection Agency (EPA) have all classified NDMA as a probable human carcinogen based on the results of animal studies. The U.S. Department of Health and Human Services (DHHS) agrees, noting that NDMA caused tumors in numerous species of experimental animals.

NDMA Linked with Pancreatic Cancer

Exposure to NDMA can lead to the development of cancer. Scientists have found this mainly in animal studies and some human studies.

According to the WHO report noted above, there appears to be no difference in how animal tissue and human tissue respond to the presence of NDMA—both can suffer from cancerous changes. In one case of suspected NDMA poisoning of a human male, researchers found that pancreatic cells exposed to the chemical formed free radicals that can lead to DNA damage.

In a 2019 study of over 36,000 workers in the rubber industry, results showed that exposure to NDMA was linked to an increased risk of all cancer, including pancreatic cancer. Lifetime cumulative exposure to rubber dust and fumes was linked to increased mortality from all cancers, and specifically to pancreatic cancer.

The researchers concluded that consistent with previous studies, “N-nitrosamines exposures are associated with mortality from cancers of the bladder, lung, stomach, leukemia, multiple myeloma, esophagus, prostate, pancreas, and liver.”

In earlier research on dietary intake of nitrosamines (remember that NDMA is found in cured and processed meats), researchers reviewed several studies involving exposure to nitrosamines and pancreatic cancer. The scientists noted that these carcinogens induce DNA damage in the pancreatic ducts, where they can cause tumors to grow.

When looking at data from over 17,600 men in the U.S., scientists found that smoking increased the risk of pancreatic cancer, but they also found that those men in the highest quartile of meat intake had about three times the risk of those in the lowest quartile. Another study from Sweden found that smoking increased the risk of pancreatic cancer, but so did high consumption of fried and grilled meat—both of which can contain nitrosamines.

A study out of China found similar results—while eating more fruits and vegetables was protective against pancreatic cancer, eating more deep-fried, cured, and smoked meats increased the risk of the disease, “providing clues to the possible roles of nitrosamines…” the researchers wrote.

In a more recent study on nitrosamines, scientists noted that NDMA and NDEA (N-nitrosodiethylamine) were the most prevalent nitrosamines found in foods. They investigated nearly 1,000 people and found significant positive associations between dietary exposure to both chemicals and pancreatic cancer.

Zantac Developers Ignore Early Warnings About Ranitidine

Zantac (ranitidine) belongs to a class of medications known as “H2-blockers” that help decrease the production of stomach acid. GlaxoSmithKline (GSK), which developed the drug, received initial FDA approval in 1983. At that time, it was a prescription drug meant for treating gastric ulcers, heartburn, acid indigestion, sour stomach, and other gastrointestinal conditions.

Even back then, there was evidence that ranitidine could form NDMA, mainly because it contained a dimethylamine (DMA) group within the molecule that when combined with nitrates, could react to form the carcinogen. Nitrites are found not only in foods, but in bacteria and enzymes in the body, so it was reasonable to be concerned about the possibility of these two chemicals reacting to produce NDMA.

In a 1981 article in the scientific journal The Lancet, an Italian researcher wrote about laboratory experiments he had conducted on cimetidine (another H2 blocker) and ranitidine in human gastric fluid. He found that when ranitidine was exposed to gastric fluid in combination with nitrites, the result showed “toxic and mutagenic effects.” He recommended that patients taking ranitidine should consider a diet “low in nitrates and nitrites,” and that doctors may want to suggest that patients not take these medications with meals.

In response, GSK researchers noted they were concerned about the potential formation of nitrosamines during the digestion of ranitidine but argued that such a conversion would not likely occur in real-world experiences.

Other studies followed discussing ranitidine’s toxic effects, but GSK moved forward with the drug, and by 1986, Zantac had become wildly successful. In 1996, it was approved for use without a prescription, and generic forms became available the following year. Both forms of the drug have remained highly profitable.

NDMA Discovered in Zantac and Generic Ranitidine

For decades, millions of people took Zantac and generic ranitidine, trusting they were safe. Then in June 2019, online pharmacy Valisure detected NDMA during routine testing of the products. The company notified the FDA of its findings, but the FDA did not take action at that time.

The FDA had already been investigating NDMA in blood pressure drugs like valsartan and losartan and had overseen the recall of several of those products. The agency traced the chemical back to unsafe manufacturing processes. 

Meanwhile, Valisure remained concerned, and on September 9, 2013, sent a citizen’s petition to the FDA urging them to recall Zantac, as well.

The FDA followed on September 13, 2019, with a safety communication warning healthcare providers and the public that NDMA had been discovered in Zantac and ranitidine products, but that the levels were low.

At that time, the agency stopped short of recommending consumers stop using the product, but did encourage manufacturers to test their products. Many of those tests also showed the presence of NDMA, and several companies recalled their products from the market. Current Zantac manufacturer Sanofi pulled its products from the shelves in October 2019.

Valisure, meanwhile, argued that unlike blood pressure drugs that contained NDMA because of manufacturing errors, ranitidine could form the carcinogen all by itself. Petition authors David Light, Valisure CEO, and Kaury Kucera Ph.S., Chief Scientific Officer, wrote: “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 ng after ranitidine intake, while total N-nitrosamine increased 5-fold.

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

While individual companies continued to recall ranitidine products through the end of 2019, the FDA held off requesting a full recall until April 1, 2020. On that date, the agency explained that as a result of recent tests on the drug, it was requesting the withdrawal of all forms of ranitidine from the market.

Those tests showed that ranitidine could become unstable under elevated temperatures of about 158 degrees Fahrenheit—the same temperatures that could occur within closed vehicles during transportation and storage. Additional tests showed that the older the ranitidine product was, 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 Pancreatic Cancer Lawsuits

The plaintiff mentioned at the beginning of this article is just one of the hundreds who have filed new Zantac lawsuits against the manufacturers of the drug. Many of these plaintiffs took Zantac for years and then were diagnosed with cancer. Others are now concerned about the additional medical monitoring they will require since they feel their risk of cancer is elevated.

The number of Zantac lawsuits continues to increase every month. 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 for more efficient pre-trial proceedings. District Judge Robin L. Rosenberg was appointed to oversee the litigation.

If you took Zantac or ranitidine regularly and were later diagnosed with pancreatic 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.