FDA continues to warn of risks, yet some advocates claim there is ‘misinformation’ surrounding the herbal drug
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.
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)
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.
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.
"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.
(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."
"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.
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.
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.
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."
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.
"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."
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