NDMA Cancer Risk and Side Effects

NDMA (N-nitrosodimethylamine) is a dangerous cancer-causing chemical that has recently been detected in some medicines. Water and many foods may contain low levels of NDMA but those levels are typically not high enough to cause harm. But recently the Food and Drug Administration (FDA) has found NDMA in higher-than-recommended levels in some medicines. Some lots of medicines, such as Zantac® (ranitidine), an antacid, have been recalled. Some medicines, such as valsartan, a medicine used to treat high blood pressure and, in some cases, heart failure, and metformin, a drug for type-2 diabetes, are being subjected to further testing.

There are patients who have contracted certain types of cancer after taking Zantac or other ranitidine drugs or valsartan who are filing Zantac lawsuits and valsartan lawsuits.

What is NDMA?

NDMA is an organic chemical. It is a yellow liquid and has no particular odor. It is not currently produced in the United States or used commercially in the U.S. except for research. NDMA used to be used in the production of liquid rocket fuels but that practice ended when high levels of NDMA were then found in air, water, and soil samples taken from areas near a rocket fuel manufacturing facility.

Where Does NDMA Come From?

In spite of not being intentionally produced in the U.S., except for research purposes, NDMA is created as a by-product of various manufacturing and natural processes via chemical reactions.

For example, processes that involve alkylamines, which are naturally occurring and man-made compounds found in the environment, may produce NDMA via chemical reaction. Industrial sources that involve alkylamines include:

• Dye manufacturers
• Fish processing plants
• Foundries
• Pesticide manufacturing plants
• Rubber and tire manufacturers
• Tanneries

NDMA is also an unintended by-product of chlorination of drinking water and wastewater at treatment plants that use chloramines for disinfection.

Common Sources of NDMA Exposure

People may be exposed to NDMA through a wide variety of sources—environmental, consumer, and occupational. Again, water and many foods contain some amount of NDMA, but those levels are typically not high enough to cause harm.

NDMA exposure can occur by, among other things:

• Eating food that contains nitrosamines, such as cured or smoked meats and fish
• Drinking contaminated water
• Eating foods that contain alkylamines, because a chemical reaction in the body can then cause NDMA to form in the stomach
• Drinking malt beverages (such as beer and whiskey); they may contain low levels of nitrosamines formed during processing
• Using cosmetic products or toiletries that contain NDMA, as some shampoos and cleaning products do
• Breathing or inhaling cigarette smoke or chewing tobacco

Examples of where occupational (work) exposure may occur include:

• Pesticide manufacturing plants
• Rubber and tire plants
• Tanneries
• Fish processing facilities
• Dye manufacturing plants
• Foundries

NDMA in Zantac (Ranitidine), Valsartan, and Other Drugs

Recently NDMA has been found in higher-than-recommended levels in some medicines, including Zantac and Valsartan. Why now, after those drugs have been on the market for quite a few years?

The most plausible theory is that manufacturing processes have changed. As noted, for example, processes that involve alkylamines may produce NDMA via chemical reaction. It is possible that drugs being investigated now contain too-high levels of NDMA due to just such a chemical reaction during the manufacturing process.

Health Effects and Symptoms of Dangerous NDMA Exposure

Organs that may potentially be affected by NDMA include:

• Bladder
• Kidneys
• Liver
• Lungs
• Pancreas
• Stomach

NDMA is especially harmful to the liver.

Possible symptoms of overexposure to NDMA include:

• Jaundice
• Nausea
• Fever
• Vomiting
• Dizziness
• Abdominal (stomach) cramps

High levels of exposure can also cause reduced function of the lungs and kidneys as well as severe liver damage and internal bleeding.

NDMA and Cancer

The Environmental Protection Agency (EPA) has classified NDMA as a probable human carcinogen. The U.S. Department of Health and Human Services (DHHS) says that NDMA is reasonably anticipated to be a human carcinogen. And the International Agency for Research on Cancer (IARC) has classified NDMA as probably carcinogenic to humans.

Dr. William Mitch, a professor of civil and environmental engineering and wastewater expert at Stanford University, told ABC News that NDMA acts as a carcinogen “because it modifies your DNA.”

Long-term exposure to NDMA has been linked to many types of cancer. Trustwell is accepting Zantac cases involving these five cancer types:

• stomach cancer
• liver cancer
• cancer of the esophagus
• pancreatic cancer
• bladder cancer