Groups urge regulation and improved testing of kratom amid overdose claims.
Despite FDA's warnings, some advocates argue that there is 'misinformation' surrounding the herbal drug.
Amid the fourth wave of the opioid epidemic crisis in the U.S., an increasing number of individuals are seeking relief from pain through non-opioid alternatives, including kratom.
Between Jan. 2020 and Dec. 2022, overdose deaths caused by kratom were found to be between 1.5% and 1.7% by medical examiners and coroners.
According to data from the State Unintentional Drug Overdose Reporting System (SUDORS) shared by the Centers for Disease Control and Prevention (CDC) with Planet Chronicle Digital, the number of opioid overdoses in the United States has been steadily increasing.
Here's a closer look at this important issue.
What is kratom?
Lori Karan, M.D., a professor of internal and preventive medicine at Loma Linda University in Loma Linda, California, stated that kratom is extracted from the leaves of a Mitragyna speciosa, a Southeast Asian tree native to Malaysia and Thailand.
The tree's leaves contain over 40 active compounds, with mitragynine, 7-hydroxymitragynine, and speciofoline being the most prominent.
The plant is thought to have dual properties.
According to Dr. Richard Clark, medical director of the San Diego division of the California Poison Control System, the substance produces a stimulant effect at low doses and an opioid-like analgesic effect when taken in higher amounts.
According to Clark, the drug has activity at opioid receptors in the brain, similar to opioid analgesics, which is why it has been used as a substitute for opioid analgesics or to alleviate symptoms of opioid withdrawal.
Despite being prohibited in six states - Alabama, Arkansas, Indiana, Rhode Island, Vermont, and Wisconsin - kratom products can still be purchased online and in stores nationwide.
In the United States, there are no specific laws prohibiting the possession of kratom, according to Clark.
In 2022, a national survey on drug abuse found that approximately two million Americans aged 12 and older used kratom in the past year.
According to the FDA's website, no drug products containing kratom or its two primary chemical components are legally available in the U.S. market.
"No prescription or over-the-counter drug products containing kratom or its two primary chemical components, mitragynine and 7-hydroxymitragynine (7-OH-mitragynine), have been approved by the FDA."
Potential risks of kratom
Experts warn that the composition of kratom can vary widely and may not accurately reflect the product labeling, despite vendors advertising it as safe and "all natural."
Clark cautioned that while kratom rarely causes severe toxicity, consuming large quantities or mixing it with other drugs can lead to hallucinations, seizures, coma, and, in rare instances, death.
According to Karan, other side effects may include nausea, dizziness, confusion, and tremors.
The FDA spokesperson informed Planet Chronicle Digital that despite warnings about the risks of kratom use, the agency continues to receive reports of adverse events associated with its use by the public.
"Consumers have been advised by the FDA not to use kratom due to the potential for severe side effects, including liver damage, seizures, and addiction."
Kratom’s role in overdose deaths
According to the SUDORS report, kratom was detected in 2,966 cases among the 144,189 overdose deaths between 2020 and 2022, indicating that some amount of the substance was found in post-mortem toxicology testing, but not necessarily as a cause of death.
The SUDORS report contains information from 31 locations.
Experts say that when kratom is discovered in post-mortem testing in overdose cases, the deaths are usually caused by the combination of multiple medications, not just kratom.
"Most fatal overdoses occur in persons who have consumed other substances in addition to kratom."
According to Karan, most fatal overdoses involve individuals who have also used other substances alongside kratom.
Advocates speak out against claims
The American Kratom Association, located in Virginia, advocates for the right of Americans to consume kratom in a safe and responsible manner.
The study found that kratom was present in a small percentage of more than 300,000 fatal overdoses.
According to research, almost all deaths linked to kratom use involved the use of multiple drugs, which is not surprising since many individuals with drug addiction issues have found kratom to be helpful in reducing their dependence on more dangerous substances, as stated by Mac Haddow, a senior fellow on public policy at the American Kratom Association, in an interview with Planet Chronicle Digital.
Although there is a possibility that a consumer could harm themselves by misusing kratom products, such incidents are infrequent and not linked to the safety of kratom when consumed responsibly.
On its website, the FDA stated that deaths from kratom use alone are rare and usually occur in combination with other drug use, making it difficult to determine the role of kratom in these fatalities.
According to Cornel N. Stanciu, M.D., the director of addiction services at New Hampshire Hospital and an assistant professor of psychiatry at Geisel School of Medicine at Dartmouth, there have been no deaths attributed solely to kratom use.
Medical examiners attribute overdoses to kratom, and the doctor is currently working on a paper examining this issue.
Stanciu stated that there is significant variation in the way reporting and testing are being conducted.
Medical examiners are not comprehensively tested for active metabolites of kratom, as most labs do not test for them after someone dies.
"More concerning is that even when toxic substances are discovered, some may still refer to it as a kratom-only death," she warned.
Calls for regulation in testing
The U.S. District Court for Southern California requested evidence from the FDA on Feb. 8 that kratom is harmful.
The FDA did not attend the hearing, and the U.S. attorney informed the court that the FDA has not yet determined whether kratom is harmful, as stated by the attorney to Planet Chronicle Digital.
The FDA declined to comment on ongoing litigation when contacted for comment.
Haddow claimed that the FDA's recent human dose-finding study showed that no significant adverse events occurred when participants took kratom, even at high doses.
"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 FDA presented at a scientific conference in February 2024 that "kratom appears to be well-tolerated at all dose levels," according to Haddow.
An FDA spokesperson stated that the pilot study on dose-finding conducted by the FDA is still blinded and involves a small sample, and the data is preliminary and unvalidated.
The FDA spokesperson stated that we must await the final analysis before drawing any definitive conclusion or interpreting the results.
"We expect the pilot data to be informative and useful for future botanical kratom studies."
The FDA's top priority under its Overdose Prevention Framework is to safeguard the public from the dangers of unauthorized drug substances, including kratom, the agency informed Planet Chronicle Digital.
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