Published: Wed, November 15, 2017
Medicine | By Douglas Stevenson

FDA Warns of Herbal Supplement Kratom's Opioid-Like Harms


Because kratom is largely unregulated, "you never know the real strength, ingredients, or how it's prepared", says Chris Barth, who used the medication Suboxone to recover from a pain pill addiction a decade ago.

The herbal supplement is a psychoactive drug derived from the leaves of the kratom plant and it's been reported that people are using the supplement to get high and some states are banning the supplement.

"There are now no FDA-approved therapeutic uses of kratom", said Gottlieb.

But the FDA said Tuesday that kratom carries similar risks, including addiction and death, and the agency is working to block shipments. He said that calls to USA poison control centers involving kratom increased 10-fold between 2010 and 2015, and that the herb is associated with side effects including seizures, liver damage and withdrawal symptoms.

But in a statement, FDA commissioner Scott Gottlieb said there is no "reliable evidence" to support the use of kratom as a treatment for opioid-use disorder, and that there are no other FDA-approved uses of kratom.

But the Food and Drug Administration is warning consumers about the "deadly risks" linked to taking the substance.

Kratom has a particular compound, called mitragynine, which binds to the same receptors that opioids like heroin does, Chemical & Engineering News reported. Additionally, the FDA is aware of reports of 26 deaths associated with the use of kratom-containing products, and that there have been reports of kratom being laced with other opioids like hydrocodone.

"At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning". Anita Gupta, an osteopathic anesthesiologist and licensed pharmacist, has expressed concern about an increase in the use of kratom among her chronic pain patients.

The health regulator has also taken action against kratom-containing dietary supplements.

Gottlieb said he was sympathetic but said distributors have to show that kratom does work as advertised.

"While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound science and weighed appropriately against the potential for abuse", Gottlieb added.

"They must be put through a proper evaluative process that involves the DEA and the FDA".

For now, kratom is widely available online and in some stores.

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