By C. Michael White
When consumers get a prescription drug from the pharmacy, they assume that it's been tested and is safe to use. But what if a drug changes in harmful ways as it sits on the shelf or in the body?
One dangerous result has been the creation of N-nitrosodimethylamine (NDMA), a probable carcinogen, in certain drugs. NDMA is found in chlorinated water, food and drugs in trace amounts. To minimize exposure, the Food and Drug Administration has set an acceptable level of NDMA in each pill at less than 96 nanograms.
But over the past few years the FDA has found excessive amounts of NDMA in several drugs for hypertension, diabetes and heartburn. As a result, the agency has initiated recalls to protect the public. These products were contaminated with NDMA during the manufacturing process. The FDA recommended best practices for manufacturers to minimize this risk going forward.
Unfortunately for the buying public, emerging evidence suggests that NDMA can also be created as some pills sit on the store shelf or medicine cabinet, or even after the patient swallows it. Thus, there is no way to test for its presence in the factory.
I am a pharmacist and distinguished professor who has written extensively about manufacturing issues and FDA oversight associated with both drugs and dietary supplements in the past, including the issue of NDMA contamination. In a new article, I discuss how NDMA can end up in a patient's medication if it wasn't put there during its manufacture.
NDMA Levels Creep Up After Manufacture
Ranitidine (Zantac) was a commonly used heartburn and ulcer prescription and over-the-counter medication for decades before it was recalled by the FDA on April 1, 2020. It may now be the canary in the coal mine for the post-manufacturing creation of NDMA.
In one study, investigators found that ranitidine contained only 18 nanograms of NDMA after it was manufactured. However, when stored at 158°F for 12 days – as if the drug had been left in a hot car – NDMA dosages rose above 140 ng. This is only slightly above the 96 ng limit the FDA has deemed safe, but this was only 12 days later.
In another study, storing ranitidine where it was exposed to higher temperatures or high humidity enhanced the creation of NDMA over time. This suggests that some medications can leave the factory with a safe amount of NDMA but if kept for too long at home or on the store shelf can exceed known acceptable limits by the time patients use them.
In a new study in JAMA Network Open, investigators simulated the stomach environment and found that when ranitidine was exposed to an acidic environment with a nitrite source, these chemicals could create more than 10,000 ng of NDMA.
These results support a clinical study in which urine samples were collected from 10 adults both before and after using ranitidine. After people swallowed ranitidine, the urinary NDMA doses rose from about 100 ng to more than 40,000 ng over the next day.
Other Drugs Need Closer Investigation
In another study, investigators added chloramine, a disinfectant routinely added to sterilize drinking water, to water samples that contained one of several medications that are structurally similar to ranitidine. They found that several commonly used drugs, including antihistamines (doxylamine and chlorpheniramine), a migraine drug (sumatriptan), another heartburn drug (nizatidine) and a blood pressure drug (diltiazem) all generated NDMA.
It is unclear whether the amount of NDMA created by these drugs when stored in hot and humid environments or after a patient swallows them is dangerous, as with ranitidine. I believe that more studies need to be done right away to find out. It is always better to be safe than sorry, particularly when dealing with a possible carcinogen.
Reposted with permission The Conversation.
The U.S. Environmental Protection Agency (EPA) has declared tetrachloroethylene, or PERC, a chemical used by many dry cleaners, a “likely human carcinogen.”
"The evidence against this ubiquitous dry cleaning chemical piled up for years, like dirty laundry in the corner of the room," said David Andrews, Ph.D., a senior scientist with Environmental Working Group (EWG). "It’s encouraging that EPA is completing this assessment so that health measures can be taken to protect workers and the public."
The EPA’s decision is based on the 2010 recommendation of the National Research Council, an independent scientific body that advises the federal government.
Tetrachloroethylene is a chlorinated solvent long used in dry cleaning, industrial cleaning and production of other chemicals and consumer products. Biomonitoring surveys have detected it in the bodies of a significant number of Americans. It has also been found in drinking water across the country and at EPA Superfund hazardous waste sites.
Once in the environment, the chemical breaks down into other known human carcinogens, including trichloroethylene (TCE) and vinyl chloride.
Consumers should take their dry cleaning to businesses that do not use tetrachloroethylene. The substance can remain on clothes and evaporate into the air at home, unnecessarily exposing the residents.
EWG’s Tap Water Database can be searched to identify local tap water where tetrachloroethylene has been found.
For more information, click here.
Each product featured here has been independently selected by the writer. If you make a purchase using the links included, we may earn commission.
The bright patterns and recognizable designs of Waterlust's activewear aren't just for show. In fact, they're meant to promote the conversation around sustainability and give back to the ocean science and conservation community.
Each design is paired with a research lab, nonprofit, or education organization that has high intellectual merit and the potential to move the needle in its respective field. For each product sold, Waterlust donates 10% of profits to these conservation partners.
Eye-Catching Designs Made from Recycled Plastic Bottles
waterlust.com / @abamabam
The company sells a range of eco-friendly items like leggings, rash guards, and board shorts that are made using recycled post-consumer plastic bottles. There are currently 16 causes represented by distinct marine-life patterns, from whale shark research and invasive lionfish removal to sockeye salmon monitoring and abalone restoration.
One such organization is Get Inspired, a nonprofit that specializes in ocean restoration and environmental education. Get Inspired founder, marine biologist Nancy Caruso, says supporting on-the-ground efforts is one thing that sets Waterlust apart, like their apparel line that supports Get Inspired abalone restoration programs.
"All of us [conservation partners] are doing something," Caruso said. "We're not putting up exhibits and talking about it — although that is important — we're in the field."
Waterlust not only helps its conservation partners financially so they can continue their important work. It also helps them get the word out about what they're doing, whether that's through social media spotlights, photo and video projects, or the informative note card that comes with each piece of apparel.
"They're doing their part for sure, pushing the information out across all of their channels, and I think that's what makes them so interesting," Caruso said.
And then there are the clothes, which speak for themselves.
Advocate Apparel to Start Conversations About Conservation
waterlust.com / @oceanraysphotography
Waterlust's concept of "advocate apparel" encourages people to see getting dressed every day as an opportunity to not only express their individuality and style, but also to advance the conversation around marine science. By infusing science into clothing, people can visually represent species and ecosystems in need of advocacy — something that, more often than not, leads to a teaching moment.
"When people wear Waterlust gear, it's just a matter of time before somebody asks them about the bright, funky designs," said Waterlust's CEO, Patrick Rynne. "That moment is incredibly special, because it creates an intimate opportunity for the wearer to share what they've learned with another."
The idea for the company came to Rynne when he was a Ph.D. student in marine science.
"I was surrounded by incredible people that were discovering fascinating things but noticed that often their work wasn't reaching the general public in creative and engaging ways," he said. "That seemed like a missed opportunity with big implications."
Waterlust initially focused on conventional media, like film and photography, to promote ocean science, but the team quickly realized engagement on social media didn't translate to action or even knowledge sharing offscreen.
Rynne also saw the "in one ear, out the other" issue in the classroom — if students didn't repeatedly engage with the topics they learned, they'd quickly forget them.
"We decided that if we truly wanted to achieve our goal of bringing science into people's lives and have it stick, it would need to be through a process that is frequently repeated, fun, and functional," Rynne said. "That's when we thought about clothing."
Support Marine Research and Sustainability in Style
To date, Waterlust has sold tens of thousands of pieces of apparel in over 100 countries, and the interactions its products have sparked have had clear implications for furthering science communication.
For Caruso alone, it's led to opportunities to share her abalone restoration methods with communities far and wide.
"It moves my small little world of what I'm doing here in Orange County, California, across the entire globe," she said. "That's one of the beautiful things about our partnership."
Check out all of the different eco-conscious apparel options available from Waterlust to help promote ocean conservation.
Melissa Smith is an avid writer, scuba diver, backpacker, and all-around outdoor enthusiast. She graduated from the University of Florida with degrees in journalism and sustainable studies. Before joining EcoWatch, Melissa worked as the managing editor of Scuba Diving magazine and the communications manager of The Ocean Agency, a non-profit that's featured in the Emmy award-winning documentary Chasing Coral.