A large number of manufacturers have recently recalled Zantac and related generic ranitidine medications from the market due to potential safety concerns.  Pharmacies like Walgreens, CVS, and Rite Aid have also removed these products from their shelves.  These drugs, which are used to reduce stomach acid, may contain N-nitrosodiethylamine (NDMA)—a probable human carcinogen.  

How long have Zantac/ranitidine contained this dangerous chemical?  

It’s unclear so far, but there is evidence suggesting that NDMA is not a contaminant in these drugs, but rather, a result of an inherent instability in ranitidine itself.  If that’s true, every form of the medication could put human health at risk.

NDMA has been linked with many forms of cancer, including bladder cancer.  Human and animal studies have suggested a link between the chemical and bladder cancer, and N-nitrosamines—a class of chemicals to which NDMA belongs—have been detected in the urine samples of patients with bladder cancer.

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

NDMA in Zantac Linked with Bladder Cancer

In addition to the study above, other research has linked N-nitrosamine chemicals with bladder cancer.  For example, researchers from the Ontario Cancer Institute tested urine from 50 healthy men.  Ten of those men had N-nitrosamines in their urine.  In addition, out of 4 samples from bladder cancer patients, 2 contained nitrosodibutylamine, another type of nitrosamine.  The scientists noted that possible sources of these chemicals included smoking, urinary infections, diet, and medications.

In a 1993 study from Spain—which at the time had the highest reported levels of nitrates in the drinking water within Europe—scientists looked at mortality rates from bladder cancer.  They found that the mortality rates in municipalities where water contained levels of over 50 mg/L nitrate were 38 percent higher overall compared to the rates in other regions where nitrate levels were lower.

The U.S. Iowa Women’s Health Study, which included over 21,000 women, evaluated nitrates in both the diet and drinking water in relation to the incidence of cancers of the bladder and kidney.  They found a slightly increased risk for bladder cancer among those in the top three quartiles of dietary nitrate intake.  Those in the top quartile of exposure via drinking water also had a higher risk of bladder cancer than those in the lowest quartile.

Many animal studies have shown that these chemicals are strong bladder carcinogens, and they increase the risk of cancerous tumors in the liver, esophagus, lung, stomach, kidney, and brain.  The World Health Organization (WHO) notes several animal studies that have connected NDMA with cancer, including bladder cancer.

The Environmental Protection Agency (EPA) categorizes NDMA as likely to be carcinogenic to humans based on evidence from animal studies, which show that nitrosamines like NDMA cause most types of cancer by manipulating certain genes that then lead to errors in DNA replication, abnormal cell growth, and ultimately, tumors.  The Agency also reports that research conducted on NDMA has found an increased risk of gastrointestinal and bladder tumors. 

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

Zantac and Generic Ranitidine Found to Contain NDMA

On September 13, 2019, the Food and Drug Administration (FDA) issued a statement alerting health care professionals and the public to the fact that some ranitidine medications, including Zantac, contained what the FDA then characterized as an “impurity”—NDMA.

At that time, the FDA had been investigating NDMA contamination in many blood pressure and heart failure medications, including valsartan and losartan.  Having discovered unsafe levels of NDMA in these medications in 2018, the FDA recommended several product recalls and many of these drugs were pulled from the market.

It wasn’t until June 2019, however, that the FDA became aware that NDMA may be in Zantac and generic ranitidine medications as well.  It began when online pharmacy Valisure notified the FDA that its own internal testing had discovered NDMA at high levels in ranitidine medications.

The FDA has set as a safe limit of 0.096 micrograms or 0.32 parts per million of NDMA per day.  The chemical is part of a class of carcinogenic chemicals called “nitrosamines,” and is a known environmental contaminant.  It’s also found in small amounts in food, water, and soil, and can be produced unintentionally in some industrial and drinking water treatment processes.

On September 9^th, 2019, Valisure submitted a citizen’s petition to the FDA, calling for the agency to recall all ranitidine drugs.  The pharmacy stated that its testing, along with research from Stanford University, showed that ranitidine could “react with itself” to produce NDMA at levels “well in excess of the permissible daily intake limit for this probable carcinogen.”  In other words, the NDMA was not contaminating the drug but was formed as the drug broke down during normal human digestion.

While the NDMA in blood pressure drugs seems to have been a contaminant traced back to manufacturing in China or India, Valisure explained that the ranitidine molecule itself contained both a nitrite and a dimethylamine (DMA) which “are well known to combine to form NDMA.”

The Stanford study Valisure referred to was published in 2016.  Researchers collected urine samples from 10 healthy adult volunteers over 24-hour periods before and after consumption of 150 mg of ranitidine.  They then analyzed those samples for residual ranitidine, ranitidine metabolites, NDMA, total N-nitrosamines, and dimethylamine.

The results showed that following ranitidine intake, the urinary NDMA excreted over 24 hours increased 400-fold from 110 to 47,600 ng, while total N-nitrosamines 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.”

File a Zantac Bladder Cancer Lawsuit

If you took Zantac or ranitidine regularly and were later diagnosed with bladder or other form 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.