Zantac Intestinal Cancer Lawsuits

When companies release medications onto the market, consumers have every right to expect those medications will be safe to use. It is up to the manufacturers to conduct adequate tests on the products to ensure their safety and efficacy, and to warn the public and regulators of any safety issues that may arise once the products are available.

Unfortunately, some medications end up putting consumers at risk without their knowledge. Such was the case with the heartburn medication Zantac and its related generics (ranitidine). It was released onto the market in 1983 and has been used by millions of people since then.

On September 13, 2019, however, the U.S. Food and Drug Administration (FDA) released a safety communication warning healthcare providers and the public that some samples of Zantac and generic ranitidine had tested positive for the presence of N-nitrosodimethylamine (NDMA), a cancer-causing agent.

Several product recalls soon followed, with Zantac manufacturer Sanofi recalling its products in October 2019. Consumers who took the medications for years are now understandably concerned about their risk for a variety of different types of cancer, including intestinal cancer.

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

What is Intestinal Cancer?

Intestinal cancer is a type of cancer that affects the small intestine (also called the small bowel). This is the part of the intestine that runs from the stomach to the large intestine (colon), and even though it’s called “small,” it’s actually the longest part of the digestive tract. In diameter, though, it’s only about as big around as your middle finger.

The lining of the small intestine absorbs the nutrients from food as it moves along toward the large intestine. Once the food leaves the small intestine, more than 95 percent of the useful nutrients have been absorbed. What’s left moves on into the large intestine as mostly waste.

Intestinal cancer is any cancer that develops and grows in the small intestine. (When cancer develops in the large intestine, it’s called colon or colorectal cancer.) The American Cancer Society estimates that about 11,110 Americans will be diagnosed with small intestine cancer in 2020.

Risk factors for the disease include the following:

  • Age—intestinal cancer occurs more often in people over the age of 60
  • Gender—men are slightly more at risk than women
  • Race—African Americans are more affected than people of other races/ethnicities
  • Diet—diets high in processed meats may increase risk
  • Celiac disease
  • A history of colon cancer
  • Crohn’s disease
  • Inherited conditions affecting the intestines
  • Cystic fibrosis

Symptoms of intestinal cancer are often vague and may also be caused by other, more common conditions, so it can be difficult to diagnose the disease. Unfortunately, that means it’s often diagnosed late, making treatments more difficult. Symptoms may include:

  • Belly pain
  • Nausea and vomiting
  • Unintended weight loss
  • Unusual fatigue
  • Dark-colored stools (blood in the stool)
  • Anemia
  • Jaundice

If cancerous tumors grow in the small intestine undetected, they can cause other complications such as intestinal obstruction or perforation. Treatments for intestinal cancer depend on how far it has spread and may include surgery, chemotherapy, and radiation. When caught in its early stages, the disease has a 5-year survival rate of 86 percent, according to the American Cancer Society. When all stages are combined, the survival rate is 68 percent.

What is NDMA?

NDMA belongs to a class of cancer-causing chemicals called “nitrosamines.” It was once commercially produced in the U.S. to make rocket fuel, but after researchers found elevated levels of it in the air, water, and soil surrounding rocket fuel manufacturing plants, they stopped using it. NDMA is no longer commercially produced in this country except as a research chemical, where it is used to induce cancerous tumors.

NDMA may no longer be produced on purpose, but it can still exist as a byproduct of several industrial and manufacturing processes, as well as drinking water treatment. It can develop in foods exposed to high temperatures, such as frying, and is often present in processed meats like bacon and hot dogs. Manufacturers add nitrites to meats to increase shelf-life, flavor, and texture, and these nitrites can combine with other chemicals in the meat and in the stomach to form nitrosamines. Nitrites can also be found in crop fertilizers.

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, based mostly on animal studies and some human studies.

The U.S. Environmental Protection Agency (EPA), as well, states that NDMA is 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 Gastrointestinal Cancer

Scientists have found evidence that exposure to NDMA, particularly through the diet, can increase the risk of several different types of cancer, including gastrointestinal cancers like small intestine cancer. Animal studies suggested this connection first, but human studies have indicated similar results.

In a 2002 report from the WHO, the authors noted that based on studies conducted with laboratory animals, “ingested NDMA is absorbed rapidly and extensively…primarily from the lower intestinal tract.” They added that animal subjects exposed to NDMA through their diet suffered from gastrointestinal hemorrhages.  

In a human study of 23,000 men and women aged 40-79, dietary intake of NDMA was significantly associated with an increased risk of gastrointestinal cancers, particularly rectal cancer. In another study, researchers followed about 10,000 Finnish men and women for 24 years. By the end of the study, 189 had been diagnosed with gastrointestinal cancers.

Processed meats are one of the main items in the human diet that contain nitrosamines, and scientists continue to find that a high intake of these items can lead to digestive cancers. In a large review of the research, scientists found an association between nitrite and nitrosamine intake and gastrointestinal cancer, with a relatively large number of studies showing consistent results supporting a positive link between processed meat intake and gastrointestinal cancer.

Research in the Netherlands also showed a connection between the dietary intake of nitrosamines and gastrointestinal cancer. Scientists studied over 120,000 men and women aged 55-69 years, analyzing their diets and cancer occurrence over a period of about 16 years. Results showed a positive association between the intake of NDMA intake, in particular, and the risk of gastric (stomach) cancer.

NDMA Discovered in Zantac and Generic Ranitidine

When the FDA warned about NDMA in Zantac (ranitidine) in September 2019, most consumers were shocked. No one had expected that such a common heartburn drug could contain a cancer-causing agent.

The FDA had been investigating NDMA in blood pressure drugs since 2018 after tests showed the presence of the carcinogen in medications like valsartan and losartan. No one thought that Zantac may be similarly contaminated, however, until online pharmacy Valisure said something.

During its routine testing of products sold, Valisure discovered that Zantac and generic ranitidine products contained unsafe levels of NDMA. It notified the FDA of its findings, and then on September 9, 2013, sent a citizen’s petition to the FDA. Authors David Light, CEO, and Kaury Kucera, Chief Scientific Officer, urged the FDA to recall all forms of ranitidine from the market.  In its petition to the FDA, Valisure suggested that ranitidine was a naturally unstable molecule and could break down during the digestion process to create NDMA. Light and Kucera 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.

 

The FDA followed with its warning to September 13, 2019, but the agency stopped short of recommending consumers stop using the product.  At that time, the FDA appeared to reject the notion 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.”   However, as more companies discovered the chemical in their products, many recalls followed, with Zantac manufacturer Sanofi pulling its products from the shelves in October.

FDA Recalls All Ranitidine from the Market

Despite the questions about where the NDMA is coming from, on April 1, 2020, the FDA requested the withdrawal of all ranitidine products remaining on the market. This move was made in response to third-party studies that found the NDMA in ranitidine increased over time and with exposure to high temperatures.

A few months before the FDA’s decision, independent laboratory Emery Pharma sent a citizen’s petition to the agency. Emery President and CEO Ramin Najafi, Ph.D. revealed that a preliminary analysis of ranitidine revealed that while stable at room temperature, the molecule could become unstable under elevated temperatures of about 158 degrees Fahrenheit.

“This was concerning,” wrote Janafi, “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, or the longer the period since it was manufactured, 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 Intestinal Cancer Lawsuits

Consumers who trusted Zantac for years or even decades are now worried about their cancer risk. Several have already filed Zantac lawsuits in courts around the country, seeking to recover damages after a cancer diagnosis, or seeking to recover the expense of increased medical monitoring.

The number of Zantac lawsuits has increased over the last several months and is expected to continue to rise. Plaintiffs blame the manufacturers for:

  • failing to provide a safe product
  • failing to warn about the risks
  • failing to take appropriate action as soon as they learned about the potential for Zantac to expose consumers to NDMA.

Indeed, there was evidence decades ago suggesting ranitidine could be toxic. A 1983 study published in the scientific journal Toxicology Letters, for instance, explored the potential for ranitidine to react under acidic conditions to form dangerous nitrosamines. In a related study that same year, researchers reported that nitrites (which are found in some foods) could react with ranitidine in human gastric juice to produce a mutagenic response.

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 intestinal 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.