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Amid kratom overdose claims, groups call for regulation, better testing of drug

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Amid kratom overdose claims, groups call for regulation, better testing of drug

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As the U.S. weathers its fourth wave of the opioid epidemic crisis, more people are turning to non-opioids — including a natural remedy known as kratom — to combat their pain.

Yet medical examiners and coroners have found that kratom caused 1.5% to 1.7% of overdose deaths between Jan. 2020 and Dec. 2022. 

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That’s according to data from the State Unintentional Drug Overdose Reporting System (SUDORS) that the Centers for Disease Control and Prevention (CDC) shared with Fox News Digital.

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Here’s a closer look at this important issue.

What is kratom? 

“Kratom is derived from the leaves of a Mitragyna speciosa, a Southeast Asian tree found in Malaysia and Thailand,” Lori Karan, M.D., professor of internal and preventive medicine at Loma Linda University in Loma Linda, California, told Fox News Digital.

Medical examiners and coroners have found that kratom — which is often ingested in capsule form — caused 1.5% to 1.7% of overdose deaths between Jan. 2020 and Dec. 2022.  (iStock)

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The leaves of the tree have more than 40 different active compounds; the most primary is mitragynine, 7-hydroxymitragynine and speciofoline. 

The plant is thought to have dual properties.

It produces a stimulant effect at low doses, and an opioid-like analgesic effect when taken in higher amounts, according to Dr. Richard Clark, medical director of the San Diego division of the California Poison Control System.

“It has activity at opioid receptors in the brain (like opioid analgesics), and for that reason has been used as either a substitute for opioid analgesics or a tool to improve symptoms of opioid withdrawal,” Clark told Fox News Digital.

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Americans most commonly use kratom for self-treatment of chronic pain and to help battle opioid withdrawal symptoms, he said.

The drug is banned in six states — Alabama, Arkansas, Indiana, Rhode Island, Vermont and Wisconsin — although people can still buy products prepared from kratom leaves online and in stores across the U.S.

Kratom is derived from the leaves of a Mitragyna speciosa, a Southeast Asian tree found in Malaysia and Thailand. (iStock)

“There are currently no specific laws against possession of kratom in the United States,” Clark noted.

Approximately two million Americans aged 12 and older used kratom in the past year, according to a 2022 national survey on drug abuse.

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“There are no drug products containing kratom or its two main chemical components that are legally on the market in the U.S.,” according to the website of the U.S. Food and Drug Administration (FDA). 

“FDA has not approved any prescription or over-the-counter drug products containing kratom or its two main chemical components, mitragynine and 7-hydroxymitragynine (7-OH-mitragynine).”

Potential risks of kratom

While vendors may advertise kratom as safe and “all natural,” the composition can vary widely and may not accurately reflect the product labeling, experts caution.

It’s uncommon for kratom to cause major toxic effects, but when people ingest large amounts or combine it with other drugs, they may experience hallucinogenic reactions, convulsions, coma and, in rare cases, death, Clark warned.

“There is also a potential for individuals to develop dependence and withdrawal with heavy kratom use,” he said.

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Other side effects may include nausea, dizziness, confusion and tremors, according to Karan.

“Despite U.S. Food & Drug Administration warnings of the risks of kratom use, the agency continues to receive concerning reports of adverse events associated with its use by the public,” an FDA spokesperson told Fox News Digital.

“The FDA has also warned consumers not to use kratom because of the risk of serious adverse events, including liver toxicity, seizures and substance use disorder (SUD).”

Kratom’s role in overdose deaths 

Among the 144,189 overdose deaths between 2020 and 2022, kratom was “detected” in 2,966 cases, according to the SUDORS report, which means some amount of the substance was detected in post-mortem toxicology testing, whether or not it was a cause of death.

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(The SUDORS report includes data from 30 states and Washington, D.C.)

Kratom was “involved” in the deaths of 2,343 cases — which means medical examiners and coroners listed it as a cause of death. (iStock)

Kratom was “involved” in the deaths of 2,343 cases, which means medical examiners and coroners listed it as a cause of death.

When kratom is found in post-mortem testing in overdose cases, the deaths almost always occur as a result of multiple medications — not just kratom, experts say.

“Most fatal overdoses occur in persons who have consumed other substances in addition to kratom.”

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“Most fatal overdoses occur in persons who have consumed other substances in addition to kratom,” Karan told Fox News Digital. 

In many cases, people were also taking fentanyl, alcohol or medication for anxiety or depression.

Advocates speak out against claims

The American Kratom Association, based in Virginia, supports the right of Americans to consume kratom in a safe and responsible way.

Advocates for kratom noted that the substance was found in a small minority of more than 300,000 lethal overdoses in the study.

“Research shows that virtually every death associated with the consumption of kratom involved polydrug use, which is not surprising given that many afflicted with drug use disorders have found kratom helps them to wean off more dangerous drugs,” Mac Haddow, senior fellow on public policy at the American Kratom Association, told Fox News Digital.

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When kratom is found in post-mortem testing in overdose cases, the deaths almost always occur as a result of multiple medications, not just kratom, experts say. (iStock)

“While it is possible that a consumer could harm themselves by abusing kratom products, like most consumer products already on the market, those occasions are both rare and not related to the safety profile of kratom when it is responsibly consumed,” he added.

The FDA also said that it’s rare for deaths to occur from kratom use alone, and that these deaths usually occur in combination with other drug use, concluding that “the contribution of kratom in the deaths is unclear,” as stated on its website.

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Cornel N. Stanciu, M.D., director of addiction services at New Hampshire Hospital and assistant professor of psychiatry at Geisel School of Medicine at Dartmouth, told Fox News Digital that to her knowledge, there have been no deaths in which kratom was the only involved substance.

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The doctor is currently working on a paper examining overdoses that are attributed to kratom by medical examiners.

One of the FDA’s top priorities as part of its Overdose Prevention Framework is to protect the public from the risks of unapproved drug substances, including kratom, the agency told Fox News Digital. (REUTERS/Andrew Kelly/File Photo)

“So far, what I am seeing is that there is tremendous variability in reporting and testing,” Stanciu said.

Comprehensive testing is lacking among medical examiners, she noted, with most labs not testing for active metabolites of kratom after someone dies. 

“Second — and more concerning — I am seeing that even when more toxic substances are found, some may still call it a kratom-only death,” she cautioned. 

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Calls for regulation in testing 

Haddow from the American Kratom Association claimed there is “rampant misinformation” associated with kratom risks — and argues for standardized toxicology testing protocols to better determine the substance’s role in overdoses.  

On Feb. 8, he noted, the U.S. District Court for Southern California requested that the FDA present supporting evidence that kratom is dangerous.

Advocates and experts are calling for more regulations and standardization surrounding testing of kratom. (Don Emmert/AFP via Getty Images)

“The FDA refused to attend the hearing and the U.S. attorney explained to the court that the FDA ‘has not yet determined whether kratom is dangerous,’” he told Fox News Digital.

When contacted for comment, the FDA told Fox News Digital that it “does not comment on possible, pending or ongoing litigation.”

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The FDA recently conducted a human dose-finding study, which found that no significant adverse events occurred when participants took kratom, even at high doses, Haddow claimed. 

“The FDA has warned consumers not to use kratom because of the risk of serious adverse events, including liver toxicity, seizures and substance use disorder.”

The finding, which the FDA presented at a scientific conference in February 2024, was that “kratom appears to be well-tolerated at all dose levels,” Haddow added.

“The FDA’s current pilot study on dose-finding was conducted in a small sample and is still blinded,” an FDA spokesperson noted, cautioning that the data is preliminary and unvalidated.

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“We need to wait until final analysis to draw any definitive conclusion or interpretation of the results,” the FDA spokesperson added.

“Ultimately, we anticipate that the data in this pilot will be informative and can support future studies of botanical kratom.”

Advocates for kratom noted that the substance was found in a small minority of more than 300,000 lethal overdoses in the study. (iStock)

One of the FDA’s top priorities as part of its Overdose Prevention Framework is to protect the public from the risks of unapproved drug substances, including kratom, the agency told Fox News Digital.

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“We will continue to collaborate with federal partners to engage proactively in meaningful research to advance science-based, regulatory decision-making,” the FDA spokesperson said.

“As new scientific and validated knowledge emerge that is based on rigorously designed studies, the agency will update the public.”

For more Health articles, visit www.foxnews.com/health.

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Ancient plague mystery cracked after DNA found in 4,000-year-old animal remains

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Ancient plague mystery cracked after DNA found in 4,000-year-old animal remains

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Long before the Black Death killed millions across Europe in the Middle Ages, an earlier, more elusive version of the plague spread across much of Eurasia.

For years, scientists were unsure how the ancient disease managed to spread so widely during the Bronze Age, which lasted from roughly 3300 to 1200 B.C., and stick around for nearly 2,000 years, especially since it wasn’t spread by fleas like later plagues. Now, researchers say a surprising clue may help explain it, a domesticated sheep that lived more than 4,000 years ago.

Researchers found DNA from the plague bacterium Yersinia pestis in the tooth of a Bronze Age sheep discovered in what is now southern Russia, according to a study recently published in the journal Cell. It is the first known evidence that the ancient plague infected animals, not just people, and offers a missing clue about how the disease spread.

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“It was alarm bells for my team,” study co-author Taylor Hermes, a University of Arkansas archaeologist who studies ancient livestock and disease spread, said in a statement. “This was the first time we had recovered the genome from Yersinia pestis in a non-human sample.”

A domesticated sheep, likely similar to this one, lived alongside humans during the Bronze Age. (iStock)

And it was a lucky discovery, according to the researchers.

“When we test livestock DNA in ancient samples, we get a complex genetic soup of contamination,” Hermes said. “This is a large barrier … but it also gives us an opportunity to look for pathogens that infected herds and their handlers.”

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The highly technical and time-consuming work requires researchers to separate tiny, damaged fragments of ancient DNA from contamination left by soil, microbes and even modern humans. The DNA they recover from ancient animals is often broken into tiny pieces sometimes just 50 “letters” long, compared to a full human DNA strand, which contains more than 3 billion of those letters.

Animal remains are especially tough to study because they are often poorly preserved compared to human remains that were carefully buried, the researchers noted.

The finding sheds light on how the plague likely spread through close contact between people, livestock and wild animals as Bronze Age societies began keeping larger herds and traveling farther with horses. The Bronze Age saw more widespread use of bronze tools, large-scale animal herding and increased travel, conditions that may have made it easier for diseases to move between animals and humans.

When the plague returned in the Middle Ages during the 1300s, known as the Black Death, it killed an estimated one-third of Europe’s population.

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The discovery was made at Arkaim, a fortified Bronze Age settlement in the Southern Ural Mountains of present-day Russia near the Kazakhstan border. (iStock)

“It had to be more than people moving,” Hermes said. “Our plague sheep gave us a breakthrough. We now see it as a dynamic between people, livestock and some still unidentified ‘natural reservoir’ for it.”

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Researchers believe sheep likely picked up the bacteria from another animal, like rodents or migratory birds, that carried it without getting sick and then passed it to humans. They say the findings highlight how many deadly diseases begin in animals and jump to humans, a risk that continues today as people move into new environments and interact more closely with wildlife and livestock.

“It’s important to have a greater respect for the forces of nature,” Hermes said.

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The study is based on a single ancient sheep genome, which limits how much scientists can conclude, they noted, and more samples are needed to fully understand the spread.

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The researchers plan to study more ancient human and animal remains from the region to determine how widespread the plague was and which species may have played a role in spreading it. 

Researchers (not pictured) found plague-causing Yersinia pestis DNA in the remains of a Bronze Age sheep. (iStock)

They also hope to identify the wild animal that originally carried the bacteria and better understand how human movement and livestock herding helped the disease travel across vast distances, insights that could help them better anticipate how animal-borne diseases continue to emerge.

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The research was led by scientists at the Max Planck Institute for Infection Biology, with senior authors Felix M. Key of the Max Planck Institute for Infection Biology and Christina Warinner of Harvard University and the Max Planck Institute for Geoanthropology.

The research was supported by the Max Planck Society, which has also funded follow-up work in the region.

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Scientists pinpoint why COVID vaccine may trigger heart inflammation in certain people

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Scientists pinpoint why COVID vaccine may trigger heart inflammation in certain people

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Aging-related joint disorder increasingly affects people under 40, study finds

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Aging-related joint disorder increasingly affects people under 40, study finds

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Cases of gout are rising in younger individuals, according to a global study.

The condition, which is a type of inflammatory arthritis, steadily increased in people aged 15 to 39 between 1990 and 2021, researchers in China announced.

Although rates vary widely between countries, the total number of young people with the condition is expected to continue rising through 2035.

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The study, published in the journal Joint Bone Spine, investigated 2021 data from the Global Burden of Disease (GBD), spanning 204 countries within the 30-year timeframe.

The data measured gout prevalence, incidence and years lived with disability, tracking global trends over time. The results showed a global increase across all three outcomes.

Gout is expected to continue rising in young people through 2035. (iStock)

Prevalence and disability years increased by 66%, and incidence rose by 62%. In 2021, 15- to 39-year-olds accounted for nearly 14% of new gout cases globally, the study found.

Men from 35 to 39 years old and people in high-income regions had the highest burden, but high-income North America topped the list for highest rates.

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Men were also found to have lived more years with gout due to high BMI, while women tended to have the condition as a link to kidney dysfunction, the study noted.

The total number of cases is expected to increase globally due to population growth, but the study projected that rates per population would decrease.

The researchers noted that data quality, especially in low-income settings, could have posed a limitation to the broad GBD data.

What is gout?

Gout is a common form of arthritis involving sudden and severe attacks of pain, swelling, redness and tenderness in the joints, according to Mayo Clinic. It most often occurs in the big toe.

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The condition occurs when urate crystals accumulate in the joint. These form when there are high levels of uric acid in the blood, which the body produces when it breaks down a natural substance called purines.

A gout flare-up can happen at any time, often at night, causing the affected joint to feel hot, swollen, tender and sensitive to the touch.

Urate crystals, described as sharp and needle-like, build up in the joint, causing intense pain and swelling. (iStock)

Purines can also be found in certain foods, like red meat or organ meats like liver and some seafood, including anchovies, sardines, mussels, scallops, trout and tuna, according to the Mayo Clinic. Alcoholic drinks, especially beer, and drinks sweetened with fruit sugar can also lead to higher uric acid levels.

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Uric acid will typically dissolve in the blood and pass through the kidneys into urine, but when the body produces too much or too little uric acid, it can cause a build-up of urate crystals. These are described by the Mayo Clinic as sharp and needle-like, causing pain, inflammation and swelling in the joint or surrounding tissue.

Risk factors for gout include a diet rich in high-purine foods and being overweight, which causes the body to produce more uric acid and the kidneys to have trouble eliminating it.

Experts urge patients to seek medical attention for gout flare-ups. (iStock)

Certain conditions like untreated high blood pressure, diabetes, obesity, metabolic syndrome and heart and kidney diseases can increase the risk of gout, as well as certain medications.

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A family history of gout can also increase risk. Men are more likely to develop the condition, as women tend to have lower uric acid levels, although symptoms generally develop after menopause.

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Untreated gout can cause worsening pain and joint damage, experts caution. It may also lead to more severe conditions, such as recurrent gout, advanced gout and kidney stones.

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The Mayo Clinic advises patients to seek immediate medical care if a fever occurs or if a joint becomes hot and inflamed, which is a sign of infection. Certain anti-inflammatory medications can help treat gout flares and complications.

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Fox News Digital reached out to the researchers for comment.

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