Zantac Testicular Cancer Lawsuits

Recent research has discovered a cancer-causing agent in the heartburn drug Zantac and its generic equivalent (ranitidine). The FDA warned the public about these findings back in September 2019 and requested manufacturers test their products. Several recalls followed, with Zantac manufacturer Sanofi withdrawing their products from the market in October 2019.

Those who took Zantac or generic ranitidine for years to treat heartburn, indigestion, ulcers, and other related conditions may now be concerned about their risk of cancer, including testicular cancer. 

Testicular cancer is rare, affecting only about one in every 250 men. For young men between the ages of 15 and 35, however, it is the most common type of cancer. Fortunately, the cure rate is excellent—greater than 95 percent of all men diagnosed with testicular cancer will survive. Still, about 400 die from the disease each year, and treatments can be difficult depending on the severity of the disease, sometimes leaving men with lasting side effects like fatigue and fertility problems.

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

What is Testicular Cancer?

Testicular cancer is a type of cancer that starts in the testicles (testes). It’s not clear what causes it, though doctors know that it develops when healthy cells in the testicle are damaged or altered. They also know that most testicular cancers start in the so-called “germ” cells, which are the ones that produce immature sperm.

Potential symptoms of testicular cancer may include a lump or enlargement in either testicle, a feeling of heaviness or sudden collection of fluid in the scrotum, a dull ache in the abdomen or groin, and pain in a testicle or scrotum. Testicular cancer seems to most commonly affect only one of the two testicles.

Testicular cancer is treated much like other cancers—with surgery, chemotherapy, and radiation. Treatment depends on how aggressive the cancer is and how far it has spread. The general 5-year survival rate for men with testicular cancer is 95 percent.

What is NDMA?

NDMA belongs to a group of chemicals called “nitrosamines” that have been qualified as potent carcinogens.

These chemicals are used in the manufacture of cosmetics, pesticides, tobacco products, and some rubber products. They can also end up in foods when nitrites, which are common food additives, come into contact with “amines” (nitrogen-containing organic compounds) in acidic places like the human stomach. High temperatures and frying can increase the formation of nitrosamines in food. Significant levels may also be found in beer, fish, and cured meats like bacon and hot dogs.

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. According to the World Health Organization (WHO), “NDMA is a potent carcinogen in experimental animals by several routes of exposure, including through ingestion of drinking water.”

The agency also stated that though there have been several case-control studies and one cohort study of NDMA in humans, none can be used to firmly say NDMA causes cancer, but the results “are supportive of the assumption that NDMA consumption is positively associated with either gastric or colorectal cancer.”

According to the Centers for Disease Prevention and Control (CDC), humans are exposed to NDMA primarily through the following sources:

  • Outdoor air, surface waters (rivers and lakes), and soil
  • Tobacco smoke, chewing tobacco
  • Cured meats (particularly bacon)
  • Beer
  • Fish, cheese, and other food items
  • Cosmetic products (shampoos and cleansers)
  • Interior air of cars, automobile exhaust
  • Detergents
  • Pesticides

NDMA Linked with Cancer, Including Testicular Cancer

Research on nitrosamines like NDMA has linked exposure to cancer. 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.

When looking specifically at testicular cancer and nitrosamines, we also see an association. In a study on animal subjects exposed to a daily intake of nitrosamines, researchers found that over half developed genital tumors, including testicular tumors. In another study on animal subjects, exposure to nitrosamines in the diet was connected to an increase in free radicals in the testes and a decrease in antioxidants—a relationship that can open the door to cancerous growth.

Studies on the intake of processed meats, which contain nitrites that can form nitrosamines during digestion, have also suggested a link with testicular cancer. After examining data from over 19,000 patients diagnosed with a variety of cancers, including testicular cancer, researchers reported in 2011 that processed meat intake was significantly related to many of these cancers, including testicular cancer. 

NDMA Discovered in Zantac and Generic Ranitidine

Online pharmacy Valisure regularly tests the products it sells. In June 2019, the pharmacy notified the FDA that it had discovered NDMA in every batch of Zantac and generic ranitidine medication tested. The FDA did not take any action at that time, but the agency had already been researching NDMA in blood pressure pills like valsartan and losartan and had overseen the recall of several of those medications.

On September 9, 2013, Valisure sent a citizen’s petition to the FDA urging it to recall all forms of ranitidine from the market. Authors David Light, CEO, and Kaury Kucera, Chief Scientific Officer, wrote: “Valisure tests all batches of all its medications for quality and consistency issues and through such tests detected extremely high levels of N-Nitrososdimethylamine(‘NDMA’), a probable human carcinogen, in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine.”

Valisure urged the FDA to request a recall and suspend the sale of all lots of all products found to contain ranitidine. The company also suggested the FDA investigate the manufacturers’ processes and inform the public of the problem. 

Valisure went on to say that the NDMA in ranitidine was not the result of contamination or manufacturing errors, as had been the case with blood-pressure drugs, but was the product of the instability of the ranitidine molecule itself.

“Valisure’s tests suggest ranitidine can react with itself,” the authors wrote, 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.

On September 13, 2019, the FDA warned doctors and the public about the discovery of NDMA in Zantac and ranitidine. The agency urged manufacturers to test their products and report their findings. Many of those tests were positive for the presence of NDMA, and several manufacturers subsequently recalled their products from the market. Sanofi, the company that markets Zantac, withdrew all forms of its products from stores in October 2019.

The FDA has so far disagreed with Valisure on the idea that NDMA might be formed in the human digestive system, however. In a statement dated November 2019, FDA Director for the Center for Drug Evaluation and Research Janet Woodcock, M.D. revealed 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.”

FDA Recalls All Ranitidine from the Market

On April 1, 2020, based on new study results concerning NDMA in ranitidine, the FDA requested the removal of all ranitidine products from the market. Information from third-party laboratories confirmed the following:

  • NDMA levels in ranitidine increase even under normal storage conditions.
  • NDMA levels in ranitidine increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during shipping and handling.
  • The older the ranitidine product, or the longer the period of time since it was manufactured, the greater the level of NDMA.

The FDA concluded that these conditions could all raise levels of NDMA to be higher than those deemed acceptable, so the agency determined that the risks associated with the medication were greater than the benefits. 

The FDA 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
  • Death

Zantac Testicular Cancer Lawsuits

Many individuals who took Zantac and ranitidine and then were diagnosed with cancer—or who are simply concerned about their risk—have filed Zantac lawsuits seeking compensation. They argue that there was evidence long ago that ranitidine could form cancerous compounds, and that the manufacturers should have warned consumers about the risks.

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 testicular 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.