FDA Underscores Risks Associated with Kratom

PUBLISHED: Feb 7, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals, Medical Office, Pharmacy

Over the past several months, there have been many questions raised about kratom, a botanical substance that has raised significant concerns given its increasing prevalence and potential safety risks. The US Food and Drug Administration (FDA) is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse, and dependence.

The FDA has been working to advance the scientific understanding of this product and how it works in the body. To that end, the FDA is now providing details of some of the important scientific tools, data and research that have contributed to increasing concerns about kratom’s potential for abuse, addiction, and serious health consequences; including death.

The FDA recently conducted a novel scientific analysis using a computational model developed by agency scientists, which provided even stronger evidence of kratom compounds’ opioid properties. The FDA has also have learned more about deaths that involved kratom use and have identified additional adverse events related to this product. This new data adds to the body of substantial scientific evidence supporting concerns about the safety and abuse potential of kratom.

The FDA has been especially concerned about the use of kratom to treat opioid withdrawal symptoms, as there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist.

The FDA reminds health care providers and consumers that there are no FDA-approved uses for kratom. FDA is actively evaluating all available scientific information on this issue and continues to warn consumers not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine.

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