FDA issues new warning on kratom

Henrietta Strickland
February 10, 2018

US health authorities say an herbal supplement promoted as an alternative pain remedy contains the same chemicals found in opioids, the addictive family of drugs at the center of a national addiction crisis.

The Food and Drug Administration has issued a new warning about the popular herbal supplement Kratom.

Dr. Sanjay Gupta, Neurosurgeon said, "Around the world kratom, an herb, has been used for centuries to help people manage pain. Importantly, as commonly used in raw plant form, it does not appear to produce the highly addictive euphoria or lethal respiratory depressing effects of classical opioids". Skeptics say the deaths can't be conclusively attributed to kratom and point out that numerous people who died also had other drugs in their systems, from alcohol to morphine. The agency is now aware of 44 kratom-associated deaths between April 2011 and last December, including one in which the individual had no known "historical or toxicologic evidence of opioid use, except for kratom". Kratom proponents have said the government sometimes blames kratom for deaths caused by other substances, but the new fatality cited by the FDA, given the absence of other substances, "reinforces our concerns", Gottlieb said.

The FDA has submitted its review to the Drug Enforcement Administration, which is considering whether to place kratom in the same category of illegal drugs as heroin and LSD. "We affirm our belief that the existing science on kratom does not justify its placement into Schedule I of the CSA, nor for kratom to be added to any local or state Controlled Substances list that would effectively remove it from consumer access". But officials backtracked after a public outcry and pressure from some members of Congress.

The FDA provided that evaluation late a year ago.

Gottlieb said his agency developed its computational model to identify the possibility of abuse of designer street drugs for which there is little pharmacological data.

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. 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.

The American Kratom Association noted that a ban on kratom could result in up to $5 billion in financial losses by 10,000 kratom-related vendors.

Warning Over Kratom: What's the Real Impact for Pain Practitioners?

"They are claiming that 44 people died from a range of causes-including just being completely unexplainable-while also using kratom", said American Kratom Association chairman Dave Herman in a statement.

Other reports by Click Lancashire

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