Zantac and Prostate Cancer

Potential Zantac Prostate Cancer Risk

Zantac and multiple generic ranitidine manufacturers have recalled their products due to concerns that they contain high levels of NDMA, a likely carcinogen.

If you or a loved one were diagnosed with prostate or another cancer after taking Zantac or the generic, ranitidine, contact us today for a free case review. Time to file your cancer lawsuit is limited.

Recent testing of samples of heartburn medications Zantac and generic ranitidine revealed small amounts of N-nitrosodiethylamine (NDMA), a probable human carcinogen.  Online pharmacy Valisure first discovered it during routine testing of products sold—noting that it was present in every Zantac sample analyzed—and informed the Food and Drug Administration (FDA). The FDA later confirmed the presence of NDMA at levels higher than those deemed acceptable and warned healthcare providers and the public.  The agency also required manufacturers to test their products, and soon a series of Zantac and ranitidine products were recalled from the market. Chaffin Luhana is currently investigating cases in which patients took Zantac or generic forms of ranitidine and then suffered serious injuries and/or prostate cancer.

What is NDMA

NDMA is a semi-volatile organic chemical that forms in both industrial and natural processes.  It is a member of a class of chemicals called “nitrosamines” that are known as potent carcinogens. NDMA is not currently produced in pure form or used commercially in the United States, except for research purposes . It was used in the past to make rocket fuel, lubricants, and other products, but its use was discontinued when it was discovered to contaminate the air, soil, and water around manufacturing plants. NDMA can still be unintentionally produced through chemical reactions involving alkylamines with nitrogen oxides, nitrous acid, or nitrite salts.  It may also be formed as a byproduct of industrial processes that occur in:
  • Tanneries
  • Pesticide manufacturing plants
  • Rubber and tire manufacturers
  • Fish processing facilities
  • Foundries
  • Dye manufacturers
NDMA is also an unintended byproduct of the chlorination of wastewater and drinking water at plants that use chloramines for disinfection.  Humans are exposed primarily through the following sources:
  • Foods that contain nitrosamines, like smoked or cured meats and fish
  • Food containing alkylamines, which can cause NDMA to form in the stomach
  • Drinking contaminated water
  • Drinking malt beverages (beer, whiskey) that may contain low levels of nitrosamines formed during processing
  • Using toiletry and cosmetic products (shampoos and cleansers) that contain NDMA
  • Breathing or inhaling cigarette smoke

NDMA Linked with Cancer, Including Prostate Cancer

Animal studies have linked NDMA exposure to cancerous tumors of the liver, respiratory tract, kidney and blood vessels.  The Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC) have classified NDMA as a probable human carcinogen. In a 2008 review on the chemical, the World Health Organization (WHO) noted: “There is conclusive evidence that NDMA is a potent carcinogen in experimental animals by several routes of exposure, including through ingestion of drinking water.” The agency went on to state 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.” Other research has indicated a potential risk of nitrosamine-caused prostate cancer.  In a 2000 study, scientists examined data from nearly 9,000 rubber workers, following them from 1981 through 1991.  They looked as their work histories—specifically, their exposure to nitrosamines and other compounds. Results 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.  The researchers also noted that among rubber workers, excess risks of prostate cancer “have been reported repeatedly among workers in maintenance and general service,” where workers may have been exposed to nitrosamines through metalworking fluids. Animal studies have also linked NDMA to prostate cancer.  One study showed that weekly ingestion of nitrosamine induced prostate cancer in 5 out of 15 subjects.  Excessive cell growth was also found in the prostate gland of 13 subjects with or without cancer. Other studies have shown mixed results, some with no evidence linking NDMA to prostate cancer, but more research is needed, as very few human studies have been completed.  Meanwhile, the evidence connecting NDMA to cancer, in general, continues to accumulate. The Minnesota Department of Health, for example, in their toxicological summary on NDMA, noted that a deficiency in available studies kept them from being able to determine safe levels of NDMA in drinking water, but “it is clear that NDMA is mutagenic and has the potential to cause health effects from less than lifetime exposures…”

Meats Containing Nitrites Linked with Increased Risk of Prostate Cancer

Of interest as well, is the connection between the consumption of processed meats, which contain nitrosamines, and prostate cancer. In 2009, researchers reported that men who eat a lot of red meat and processed meats may have a higher risk of developing prostate cancer than those who limit these foods.  Upon further examination of the data, the scientists found that red processed meats, like bacon, sausage, and hot dogs, were related to higher prostate cancer risk. The IARC later examined over 800 studies on the intake of processed meat and concluded that meat processing such as curing, which adds nitrates or nitrites, or smoking, could lead to the formation of potentially cancer-causing chemicals like N-nitroso-compounds and polycyclic aromatic hydrocarbons. The IARC’s findings led them to classify the consumption of processed meat as carcinogenic.

Zantac and Generic Ranitidine Found to Contain NDMA

The FDA has set an acceptable daily intake limit for NDMA at 0.096 micrograms or 0.32 parts per million (ppm) for ranitidine.  On September 13, 2019, the agency issued a statement warning healthcare providers and consumers that some ranitidine medications, including Zantac, were found to contain a “nitrosamine impurity” called NDMA at low levels. Consumers were advised to stop taking ranitidine and to talk to their doctors about alternatives.  Manufacturers were told to test their products.  Many of those tests detected the presence of NDMA, so many generic and name-brand manufacturers began pulling their products from the market.  Sanofi, the company that markets Zantac, withdrew all forms of its products from stores in October 2019. Though the FDA called NDMA an “impurity,” online pharmacy Valisure argued that the presence of NDMA was not the result of a manufacturing defect or contamination, but rather the result of the ranitidine molecule itself, which they described as being “unstable.”  The company sent a petition to the FDA in September 2019, describing its findings and urging the FDA to recall all forms of ranitidine medications. Valisure noted that the ranitidine molecule contains both a nitrite and a dimethylamine (DMA), which “are well known to combine to form NDMA.”  Valisure’s tests suggested that ranitidine could react with itself during digestion to produce NDMA at levels above the permissible daily limit. The company referred to a 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 researchers stated that NDMA excretion rates “equaled or exceeded those observed previously in patients with schistosomiasis, a disease wherein N-nitrosamines are implicated as the etiological agents for bladder cancer.”

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
  • Pancreatic cancer
  • Prostate cancer
  • Colorectal cancer (colon or rectal cancer)
  • Death

File a Zantac Prostate Cancer Lawsuit

Many Zantac lawsuits and Zantac class-action lawsuits have already been filed in courts around the country.  The plaintiffs claim that the manufacturers knew or should have known about the presence of NDMA in their products, yet they failed to warn consumers or healthcare providers. If you took Zantac or ranitidine regularly and were later diagnosed with prostate 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.