Zantac Uterine Cancer Lawsuits
In 2020, an estimated over 65,000 women in the United States will be diagnosed with uterine cancer, also called endometrial cancer, and over 12,500 will die from it. Uterine cancer is the fourth most common cancer for women in the United States.
Several factors can increase a women’s risk for uterine cancer including age, obesity, type 2 diabetes, polycystic ovary syndrome (PCOS), and a family history of uterine cancer. Some women may now be wondering, however, if their intake of Zantac and generic ranitidine may increase their risk too?
On September 13, 2019, the FDA warned that some samples of heartburn medication Zantac had tested positive for a carcinogen called “N-nitrosodimethylamine (NDMA).” More studies and tests followed, and on April 1, 2020, the FDA called for all forms of ranitidine to be pulled off the market. Zantac has been available for decades, however, and at this time it’s unclear how long it may have contained NDMA.
Women who took the medication regularly are understandably concerned that it may have increased their risk of cancer, including uterine cancer. Chaffin Luhana is currently investigating cases in which patients took Zantac or generic forms of ranitidine and then suffered serious injuries and/or uterine cancer.
What is Uterine Cancer?
Uterine cancer is any type of cancer that develops in the uterus, or womb—the hollow organ in females that nourishes the fetus until it is born. The uterus is about the size and shape of a medium-sized pear, and is made up of two main layers:
- Myometrium: The outer layer, made of thick muscle tissue that helps push the baby out during birth.
- Endometrium: The inner layer that lines the inside of the uterus. It’s actually made up of two layers itself—the first attaches to the muscle tissue that forms the outer layer of the uterus. The second changes in response to the monthly flux of hormones that guide the menstrual cycle. Each month, it thickens to nourish an embryo if pregnancy occurs. If there is no pregnancy, it sheds and becomes menstrual flow.
Though cancer can form in any part of the uterus, about 90 percent of the time, cancerous growth starts in the endometrium, which is why uterine cancer is also referred to as endometrial cancer. The American Society of Clinical Oncology (ASCO) states that endometrial cancer is increasing. Between 2007 and 2016, cases in white women increased by 1 percent each year, while cases in black women increased by 2 percent each year. Black women are also more likely to die from uterine cancer than white women.
Uterine cancer is the sixth leading cause of cancer death among women in the U.S. The five-year survival rate is about 81 percent overall, and 84 percent for white women and 62 percent for black women. Researchers note that black women are less likely to be diagnosed when the disease is in its early stages, which may be why their survival rate is lower. The earlier the disease is detected, the more likely treatments are to work well.
Uterine cancer may not cause any symptoms in the early stages. As it progresses, symptoms may include vaginal bleeding after menopause, bleeding between periods, pelvic pain, pain during intercourse, and trouble urinating. Treatments depend on the stage and type of cancer and typically include surgery, chemotherapy, radiation, immunotherapy, or a combination of these.
What is NDMA?
NDMA belongs to a class of chemicals called “nitrosamines,” which are naturally found in tobacco products and tobacco smoke, as well as in many foods including fish, beer, fried foods, and processed meats like bacon and hot dogs.
NDMA, in particular, can occur in drinking water when chlorination is used and is a contaminant in certain pesticides. It was commercially produced in the U.S. and used to make rocket fuel, but after unusually high levels were found in air, water, and soil samples around rocket fuel manufacturing plants, its use was discontinued.
NDMA can still be inadvertently produced in various industries, including the manufacture of pesticides, rubber tires, and dyes. It may also form under natural conditions in air, water, and soil as a result of chemical, photochemical, and biological processes, and has been detected in drinking water and automobile exhaust.
However, levels of NDMA in food have decreased in recent years because of changes in food processing, according to the World Health Organization (WHO).
The WHO states that based on laboratory studies, “NDMA is clearly carcinogenic…potentially at relatively low levels of exposure.” The U.S. Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC) have both qualified NDMA as a probable human carcinogen, based mostly on animal studies and some human studies.
NDMA Linked with Cancer, Including Uterine Cancer
Studies have shown that exposure to nitrosamines and NDMA can increase the risk of cancer in animals and humans. A 2000 study of nearly 9,000 rubber workers showed that exposure to nitrosamines was significantly associated with an increased mortality rate from cancers of the esophagus, oral cavity, and pharynx, and non-significantly associated with increased mortality from prostate and brain cancer.
A 2011 study of over 23,000 men and women aged 40-79, found that dietary intake of NDMA was significantly associated with an increased risk of gastrointestinal cancers, particularly rectal cancer.
In addition to these studies, there are a few that look at the relationship of nitrosamines to uterine cancer, in particular. In one experiment on animal subjects, for instance, scientists gave the subjects a solution containing nitrosamines for several weeks. All of the subjects developed colon cancer, and a few also developed intestinal and uterine cancers.
In another animal study, four hours after consuming a solution with NDMA, subjects showed cancerous changes in their tissues, including in the liver, esophagus, ovaries, pancreas, bladder, and uterus. Researchers noted that the data supports those studies “implicating nitrosamines in causation of cancers of the stomach and other organs,” adding that alcohol seemed to enhance the internal exposure to nitrosamines.
Other studies have looked at diet, in particular, and how it may affect uterine cancer. Since some foods contain nitrosamines, what might happen in women who consume a lot of those foods? In one study, scientists examined the nitrate intake of 103 women who were diagnosed with endometrial cancer and compared them to controls who had not. (Nitrates and nitrites are food additives that can form nitrosamines.) They found that the more foods women ate with nitrates in them, the higher their risk of endometrial cancer.
On the other hand, eating a healthy diet that avoids nitrosamines may be protective against uterine cancer. Scientists reported in 2015 that women adhering to a Mediterranean diet, which consists of vegetables, fruits/nuts, cereals, legumes, and fish, with a low intake of dairy products and meat and moderate alcohol intake, were less likely to be diagnosed with endometrial cancer than those who didn’t.
Researchers Connect NDMA Exposure to Increased Risk of Uterine Cancer
Perhaps most concerning is a recent study conducted on individuals who had potentially been exposed to NDMA via the blood pressure medication valsartan.
The FDA started investigating valsartan and other similar drugs in 2018 because some tested positive for the presence of NDMA. They traced the problem back to certain manufacturers who were not being careful enough about contamination. Several valsartan and losartan medications were recalled as a result of this investigation.
Meanwhile, scientists wanted to see if the intake of these medications might increase the risk of cancer. They looked at data from 5,150 Danish patients with no history of cancer who used valsartan from January 1, 2012, through June 30, 2017. They then tracked those participants for a median of 4.6 years to see which ones developed cancer.
The results showed no markedly increased short-term risk of cancer in those using valsartan that may have been contaminated with NDMA. For single cancer outcomes, however, there were some small increases in risk—namely, for colorectal cancer and uterine cancer.
The researchers concluded that “uncertainty persists about single cancer outcomes,” and recommended additional studies.
NDMA Discovered in Zantac and Generic Ranitidine
The FDA first warned healthcare providers that NDMA had been discovered in Zantac and ranitidine on September 13, 2019. The agency noted that it had been investigating NDMA and “other nitrosamine impurities” in blood pressure and heart failure medications, and had recommended numerous recalls in drugs that had unacceptable levels of the cancer-causing agent.
At that time, the FDA did not recommend consumers stop taking the medication, stating that the levels of NDMA found in ranitidine “barely exceeds amounts you might expect to find in common foods.” It did recommend that manufacturers start testing their products and report their results.
The FDA’s alert seemed to wake up the ranitidine industry. Several companies complied with the FDA’s recommendations to test their products, and soon several were recalling those products because they found that they contained NDMA, often at levels higher than the FDA deemed acceptable (over 96 nanograms). Sanofi, the current manufacturer of Zantac, recalled its ranitidine medications in October 2019.
Meanwhile, on September 9, 2013, online pharmacy Valisure sent a citizen’s petition to the FDA urging it to recall all forms of ranitidine from the market. The company had discovered NDMA in routine tests of Zantac and urged the FDA to take further action. Executives also suggested that in ranitidine, the presence of NDMA was not the result of a manufacturing or contamination problem, but rather, a natural by-product of human digestion of the medication.
Petition authors David Light, CEO, and Kaury Kucera, 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.
FDA Recalls All Ranitidine from the Market
Though several companies recalled ranitidine products between September 2019 and March 2020, the FDA stopped short of requiring all products to be recalled. But then the agency saw the results of new independent studies on the drug.
Independent laboratory Emery Pharma sent a citizen’s petition to the FDA on January 2, 2020. Emery Pharma is an FDA registered, GLP/cGMP compliant laboratory that investigated the stability of ranitidine to determine its potential for generating NDMA. Its preliminary analysis revealed that while stable at room temperature, the ranitidine molecule could become unstable under elevated temperatures of about 158 degrees Fahrenheit.
“This was concerning,” wrote Ramin Janafi, Ph.D., President and CEO of Emergy Pharma, “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.”
Ultimately, further tests showed that not only did NDMA increase with elevated temperatures, but also with time. The older the ranitidine product, or the longer the period since it was manufactured, the greater the level of NDMA.
Based on these findings, on April 1, 2020, the FDA requested the removal of all ranitidine products from the market. The agency sent letters to all manufacturers directing them to recall their products, and also advised consumers 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
- Kidney cancer
- Liver cancer
- Esophageal cancer
- Pancreatic cancer
- Prostate cancer
- Breast cancer
- Testicular cancer
- Colorectal cancer (colon or rectal cancer)
- Uterine (endometrial) cancer
Zantac Uterine Cancer Lawsuits
Manufacturers are responsible for thoroughly testing their products to be sure they are safe before releasing them on the market where millions of people will use them. Women who took Zantac and generic ranitidine for years thought they were using a safe product. Now, they know that at least for some of the time, those products may have contained a cancer-causing agent.
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 uterine, endometrial, 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.