The U.S. Food and Drug Administration released a statement on Tuesday afternoon from Commissioner Scott Gottlieb, MD, declaring that kratom, a southeast Asian herbal medicine, contains naturally occurring plant alkaloid chemicals that are predicted by unpublished computer models to be opioids.
The agency has also collected 44 fatal adverse reaction reports where kratom components were present in the bodily fluids of the decedents.
As a result, the agency is heightening its warning to consumers and healthcare professionals, first made in a public health advisory in November, that kratom presents a safety hazard and holds the potential for abuse.
But consumers sing kratom’s praises as a medicinal herb useful for chronic pain, anxiety and depression. Taken primarily as a tea or in capsules containing pulverized dried leaves, kratom is used by some who had been previously dependent on prescription opioids or alcohol. But the FDA states that no scientific studies support these therapeutic uses of kratom. As a result, Dr. Gottlieb’s statement concludes by urging people who are self-medicating with kratom to seek the help of healthcare professionals and prescription opioid-maintenance therapy or non-opioid pain relievers that have passed the FDA approval process.
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