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FDA Sheds Additional Light on Opioid Compounds in Kratom

February 7, 2018
Findings indicate potential harm of herbal supplement

As the United States continues to focus on opioid misuse, finding alternative treatments to combat potential abuse weighs heavy on the minds of practitioners. In addition, safe and reliable methods to treat withdrawal symptoms of opioid addiction are needed, and many products on the market that claim to achieve this are unfounded and unapproved by the FDA, posing public safety and health risks.

Kratom is a prime example. This naturally growing herbal substance native to several parts of Asia, has recently entered the US market illegally under claims of being able to treat chronic pain symptoms and other conditions.1 FDA has stepped in, concerned over the product’s lack of scientific evidence to support medical claims. As part of an agency statement on kratom, FDA shared recent data on deaths and other serious adverse effects involving the improper use of this supplement.

FDA used the Public Health Assessment via Structural Evaluation (PHASE) methodology, a 3-D tool that simulates the way in which chemical constituents of a substance are structured at the molecular level to show how they may behave inside the body, and how they can potentially affect the brain. Analyzing the chemical structures of the 25 most prevalent compounds in kratom, the agency concluded that the compounds share similarities with controlled opioid analgesics, such as morphine derivatives. Further analysis confirmed that two of the most prevalent compounds in kratom are known to activate opioid receptors, and that kratom has a strong bind to mu opioid receptors, comparable to those of scheduled opioid drugs.2

“The FDA relies on this kind of sophisticated model and simulation to supplement its data on how patients react to drugs; often as a way to fully elucidate the biological activity of a new substance,” said FDA Commissioner Scott Gottlieb, MD, in a statement regarding the PHASE study. Based on the scientific information brought on by the model, FDA concluded that compounds found in kratom are indeed opioids.

Deaths Associated with Kratom

As of February 6, 2018, FDA has reported 44 deaths involving the use of kratom; an increase from 36 reported in November 2017.3 While many of these cases could not be fully assessed because of limited information, one new report of death, in which the individual had no known historical or toxicologic evidence of opioid use besides kratom, was of particular concern. In addition, kratom is at risk of being combined with other drugs that affect the brain, including prescription opioids, benzodiazepines, and over-the-counter medications, potentially leading to further misuse. The substance continues to be placed on import alert, and has undergone various product seizures.2

“The scientific evidence we’ve evaluated about kratom provides a clear picture of the biologic effect of this substance,” said Dr. Gottlieb in the statement. “Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids.”

Instead, the agency recommended in its statement that physicians rely on other safe and effective approaches when treating patients for opioid addiction and withdrawal symptoms, including buprenorphine, methadone, and naltrexone, as well as psychosocial support and related therapies.2

Last updated on: February 9, 2018
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Warning Over Kratom: What's the Real Impact for Pain Practitioners?
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