Zantac Kidney Cancer Lawsuits

Laboratory tests have indicated that stomach acid-reducing medications Zantac and generic ranitidine may contain N-nitrosodimethylamine (NDMA), a probable human carcinogen.  Many of these products have been recalled this year, but what about the people who have been taking them for years? Is it possible the products caused harm?

If you have taken Zantac or the generic equivalents at least twice a week for a couple of years or longer and then were diagnosed with cancer, you may be eligible to file a Zantac lawsuit.  Studies have linked NDMA exposure to cancer, particularly gastrointestinal and colorectal cancers.  Animal studies have also found that NDMA exposure is associated with a potential risk for kidney cancer, as well as other types of cancers.

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

Zantac and Generic Ranitidine Found to Contain NDMA

In June 2019, online pharmacy Valisure detected NDMA in ranitidine medications.  During routine testing of the products sold on its site, Valisure found “extremely high levels” of NDMA in “every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine.”

On September 9, 2019, Valisure sent a petition to the FDA, informing the agency of its findings and asking for a recall of all ranitidine.  The FDA has set a safe limit of 0.096 micrograms or 0.32 parts per million of NDMA per day.  Valisure’s testing revealed levels in excess of 3,000,000 nanograms (3,000 micrograms) per tablet when analyzing ranitidine products.

The FDA conducted its own low-heat testing of ranitidine, and found lower levels of NDMA—but these levels were still higher than the safe limit.

On September 13, 2019, the FDA issued a statement warning healthcare providers and patients that NDMA had been found in Zantac and generic ranitidine.  The FDA had been investigating NDMA in heart failure and blood pressure drugs for months and had recommended numerous recalls of products like valsartan and losartan.

The FDA continued testing ranitidine products and instructed all ranitidine manufacturers to do the same.  Since then, many companies have initiated ranitidine recalls, either because of the confirmed presence of NDMA or because of the possibility the products could contain the carcinogen. Those companies including the following:

  • Sandoz
  • Apotex Corp.
  • Sanofi (Zantac)
  • Perrigo Company
  • Reddy’s
  • Lannett Company
  • Novitium Pharma
  • Aurobindo
  • American Health Packaging
  • Amneal
  • Golden State Medical Supply
  • PrecisionDose

Pharmacies like Walgreens, Rite Aid, and CVS have also pulled ranitidine products from their shelves.

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
  • Colorectal cancer (colon or rectal cancer)
  • Death

What Is NDMA?

NDMA is a yellow liquid that was once produced in the U.S. for use in rocket fuel.  After traces of the chemical were found in the environment around rocket-fuel manufacturing plants, however, use of NDMA was discontinued.

Today, NDMA is produced only as a research chemical.  But it can still be found in the air, water, and soil, as well as in some foods (mainly processed meats), because of reactions involving other chemicals.  It can also be a byproduct of certain industrial processes and can be unintentionally produced at drinking water treatment plants that use chloramines for disinfection.

The general population can be exposed to NDMA from a wide variety of sources, including the following:

  • Outdoor air
  • Surface waters (rivers, lakes)
  • Drinking water
  • Soil

The primary sources of human exposure to NDMA, according to the Centers for Disease Control and Prevention (CDC), are:

  • Cigarette smoke
  • Chewing tobacco
  • Diet (cured meats like bacon, beer, fish, cheese, and others)
  • Toiletry and cosmetic products (like shampoos and cleansers)
  • Interior air of cars
  • Household goods (detergents, pesticides)

NDMA can form in the stomach during digestion because of chemical reactions between alkylamines and nitrogen oxides, nitrous acid or nitrite salts.

NDMA Linked with a Variety of Cancers

Animal studies have shown that NDMA can cause cancerous tumors.  The substance damages the liver, and at high levels can cause severe liver damage.  When rats, mice, hamsters, and other small animals ate food, drank water, or breathed air containing NDMA for periods lasting longer than several weeks, they developed liver cancer and lung.  Other animal studies have linked NDMA exposure to kidney cancer.

Based on these study results, the CDC states that “it is reasonable to expect that exposure to NDMA by eating, drinking, or breathing could cause cancer in humans.”

The World Health Organization (WHO) reports that there is conclusive evidence that NDMA is a potent carcinogen in experimental animals.  The WHO adds that though there have been several case-control studies and one cohort study of NDMA in humans, “none of them can be used to derive a quantitative risk of cancer. The results are supportive of the assumption that NDMA consumption is positively associated with either gastric or colorectal cancer.”

The Environmental Protection Agency (EPA) agrees, classifying NDMA as a probable human carcinogen.  Likewise, the U.S. Department of Health and Human Services and the International Agency for Research on Cancer (IARC) classify NDMA as reasonably anticipated to be a human carcinogen.

A toxicological profile for NDMA written by the Agency for Toxic Substances and Disease Registry (ATSDR) in collaboration with the EPA indicates that rats and mice continuously exposed to 0.07 parts per million NDMA for 25 and 17 months, respectively, developed significantly increased incidences of lung, liver, and kidney tumors.

The same report refers to other animal studies showing NDMA targeting the liver and lungs primarily, but also forming tumors in the kidneys and testes.  These types of tumors were connected to dietary exposure to NDMA.  Animals exposed via drinking water for long periods were also found to be at an increased risk for liver, lung, and kidney tumors.

NDMA the Result of Ranitidine Digestion?

Valisure and other entities report that with ranitidine, NDMA is present not because of contamination, but because of an inherent instability in the ranitidine molecule itself.  Valisure pointed out in its petition to the FDA that the ranitidine molecule contains both a nitrite (N) and a dimethylamine (DMA)—which is a species of alkylamine.  These two molecules are known to combine to form NDMA.

“Valisure’s tests suggest ranitidine can react with itself,” Valisure stated, “to produce NDMA at levels well in excess of the permissible daily intake limit for this probable carcinogen.”  The pharmacy pointed to a 2016 study done by Stanford University to back up their findings.

In that study, researchers collected urine samples from healthy adult volunteers both before and after they consumed 150 mg of ranitidine.  They found that after the participants took ranitidine, the levels of NDMA excreted in their urine over 24 hours increased 400-fold from 110 to 47,600 ng.

The FDA states that the source of NDMA in ranitidine medications is still unknown and that it continues to investigate the issue.

File a Zantac Kidney Cancer Lawsuit

Many plaintiffs have already filed Zantac lawsuits in courts around the country.  They blame the manufacturers for failing to warn of the potential dangers associated with consuming their products, particularly long-term.

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