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Kratom Alert: FDA Concerns

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Dr. Kiefer reports no financial relationships relevant to this field of study.


* Kratom leaves have a long history of traditional use in Southeast Asia for a variety of health conditions.* At low doses, it appears to have stimulant effects; at higher doses, opioid-like effects are seen.* Adverse effects have been demonstrated, often associated with opioid effects or withdrawal.

SOURCE: FDA Statement. Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom. Nov. 17, 2017. Available at: Accessed Jan. 7, 2018.

This Abstract & Commentary is drawn from a U.S. Food and Drug Administration (FDA) press release, differing from the focus on randomized, controlled trials, as is more typical for Integrative Medicine Alert reviews. The primary reason for this is to highlight an important safety concern, and weave in some of the recent background research relevant to this natural product.

Kratom ( Mitragyna speciosa , Family Rubiaceae) is a tree found in Southeast Asia and Africa, and its leaves are used medicinally, usually as a tea, for a variety of health conditions. 1 In the United States, it is marketed as a safe natural substance for the treatment of pain, anxiety, and depression. As per the FDA press release, there is the concern about the self-treatment of these serious conditions, but also the fact that kratom appears to have opioid-like effects and the expected issues of addiction, withdrawal, and death; 36 deaths have been reported. Outside of the supervision of a licensed healthcare provider, kratom also is being used to treat opioid withdrawal, another FDA concern. There has been a marked increase in calls made to U.S. poison control centers about the use of kratom-containing products.

At the end of the press release, the FDA director reminded the scientific community and the...