Often, medications and other things with widely accepted uses, we ultimately discover, may not be as safe as we thought. N-nitrosodimethylamine or NDMA is an example of this.
NDMA is classified by the U.S. Food and Drug Administration as a probable human carcinogen, which means it could potentially cause cancer or increase the risk of developing it.
NDMA is a known environmental contaminant. It’s found in water, foods, the air, alcoholic beverages, and medications like Valsartan, a popular drug prescribed for high blood pressure and heart failure. In 2018, the FDA announced the recall of Valsartan products because of unsafe levels of NDMA. Now, because of that recall, there are many Valsartan lawsuits on the rise.
Below, we cover what you should know about NDMA and its potential risks.
The Basics of NDMA
In the past, NDMA was used to make a variety of commercial products. It’s a semi-volatile organic chemical that forms naturally and in industrial processes. NDMA is a yellow liquid, and the compounds, as was touched on are found at low levels in some foods and beverages.
When NDMA compounds are in foods and drinks, it’s usually because of cooking and fermentation. They may be found in roasted meats and cheeses, as well as beer, for example.
Shampoos and cleansers, pesticides, detergents, and tobacco can also expose you to NDMA. NDMA is classified as a 2A carcinogen, meaning there isn’t direct evidence it causes human cancer, but it likely does since it has led to cancer in animals.
With that being said, the FDA reports as it stands now, up to 96 nanograms of NDMA per day is considered relatively safe, based on a lifetime of exposure.
However, if a person takes above that level over a long period, they may be at an increased risk of cancer. At a level of consumption that’s at or below the limit above, every day for 70 years, a person would not be expected to face an increased cancer risk.
Food and Water Exposure
NDMA is a byproduct of chlorinating both drinking water and wastewater at treatment plants. It’s not always in public water systems, as tests have indicated, however.
The U.S. Environmental Protection Agency (EPA) uses the unregulated contaminant monitoring rule (UCMR) to monitor contaminants that may be present in water but don’t have health-based standards from the Safe Drinking Water Act.
NDMA may be part of the waste that comes from food processing and is often found in food like cured fish and meat, cheese and bacon.
Over recent years, contaminants, including NDMA, have been discovered in drugs around the world. For example, in 2018 researchers first found that medications with the ingredient valsartan contained the contaminant. Valsartan is an angiotensin receptor blocker (ARB) used in the treatment of high blood pressure.
Since that initial discovery, similar compounds as well as NDMA itself have been found in at least six medications. These are medications that are pretty commonly used by tens of millions of individuals annually.
Due to the contaminants and the potential carcinogenic effects, there have been recalls for many of these medications by regulatory agencies.
Valsartan was recalled in July 2018. Valsartan is a medication that blocks chemicals in the body that would otherwise restrict blood vessels. Taking the hypertension and heart failure medication allows blood vessels to stay open and relax, lowering blood pressure and reducing the risk of stroke or heart attack.
The levels of NDMA in valsartan were deemed unsafe, however.
More than 20 health agencies in countries around the world also recalled the drug.
NDMA is thought to have been in valsartan for at least four years, from 2015 to 2019.
Valsartan isn’t the only medicine with NDMA.
In the fall of 2019, the FDA alerted the public about the risk of NDMA in ranitidine, which is available over-the-counter as brand name Zantac. Following the warning, Zantac was pulled from shelves over the following months.
Nizatidine is another heartburn medicine in a similar situation. The manufacturer recalled nizatidine in January 2020. The FDA recently indicated manufacturers of the ingredient should recall all types of the medicine.
Metformin is a diabetes drug taken by nearly 16 million people worldwide, but since May 2020, companies have recalled more than 170 products containing it because of the presence of NDMA.
According to information from the FDA, along with requesting that certain versions of metformin be recalled while their risk is evaluated, they’re also asking manufacturers to test all batches of at-risk products before putting them on the market.
The FDA says that if testing shows there’s an amount of NDMA over the acceptable limit, the manufacturer should let the regulatory agency know and not release that batch into the marketplace.
The FDA is working with manufacturers to figure out the source of this and related contaminants and whether or not they pose a risk to humans.
As was mentioned above, the primary risk linked to NDMA is the potential for consuming too much to raise your cancer risk. In aminal studies, rats with exposure to lower levels of NDMA for more than a few weeks developed lung and liver cancer, as well as noncancerous liver exposure.
When mice were given NDMA during pregnancy, their offspring were either born dead or died soon after birth. Researchers don’t know whether or not NDMA could lead to the death of human babies when mothers are exposed to it.
There aren’t currently available reports of NDMA causing cancer in humans. However, there is an association to the point that experts say it’s reasonable to expect exposure could cause cancer in humans.
Exposure doesn’t mean any adverse health effects will definitely occur, but it’s possible.
If you believe you’ve experienced exposure and developed health problems as a result, it’s a good idea to speak to a personal injury attorney. As mentioned, lawsuits related to the contaminant are on the rise throughout the country.