DEA calls this widely used supplement a ‘drug of concern’

Over the past 7 years, exposure to kratom—an herbal supplement often used to help in overcoming opioid withdrawal and pain—has increased dramatically, according to a recent study published in Clinical Toxicology.  

This is of concern because kratom has been on the Drug Enforcement Administration’s (DEA’s) list of drugs and chemicals of concern for several years. Even more disconcerting is the fact that the FDA has neither studied nor approved kratom for any medical use.

Because kratom is not regulated, product quality, purity, and concentrations are disparate, wide-ranging, and unpredictable.

But what is perhaps most dangerous about kratom is the misperception that it is safe simply because it is “just” an herbal supplement.

Kratom is available on the internet, in raw leaf, powder, gum, capsule, tablets, and extract forms. At low doses, it causes stimulation; at higher doses, it can act as a depressant or cause euphoria, similar to opioids. Anecdotally, users have reported anti-inflammatory, antipyretic, antitussive, antihypertensive, and antidiarrheal effects, as well as enhanced sexual function.

In addition to being used to ease opioid withdrawal, kratom has also recently become popular as a treatment for chronic and acute pain, depression, and anxiety.

What is it?

Kratom is a tropical evergreen from Southeast Asia that is native to Thailand, Malaysia, Indonesia, and Papua New Guinea. Like coffee and gardenia, this tree belongs to the Rubiaceae family. Natives in these countries, where kratom has been used for many years, claim it is addictive. Its leaves can be chewed, smoked, or brewed into a tea, or taken in capsule, tablet, and extract formulations.

Kratom has opioid properties, as confirmed by the FDA, and its pain-relieving properties are due primarily to the alkaloids it contains. Of special interest among these is mitragynine, which is structurally related to yohimbine and may be the source of kratom’s opioid-like effects. It is classified as a kappa-opioid receptor agonist, and may be nearly 13 times more potent than morphine.

Recent uptick in exposures

In a recent study conducted by researchers at the Central Ohio Poison Center, and the Center for Injury Research and Policy, Nationwide Children’s Hospital, Columbus, OH, over 1,800 calls about kratom exposure were made to the US Poison Control Centers between January 2011 and December 2017.

Fully 65% of these exposures occurred between 2016 and 2017. Researchers also documented a significant increase in the annual number of calls, from 13 in 2011, to 682 in 2017.

Researchers also found that most exposures were in men (71%), those aged 20 years and older (89%), and at a residence (86%). Forty-eight incidents involved children ages 12 years or younger, 69% of whom were younger than 2 years.

Usage was classified as intentional abuse or misuse in 60%, suspected suicide in 9%, and adverse reactions in 8%. Idaho and Oregon had the highest exposure rates, and Delaware and Wisconsin the lowest.

A full 32% of the calls resulted in admission to a healthcare facility, and 52% resulted in serious medical outcomes. Problems caused by kratom exposure included tachycardia, agitation and irritability, hypertension, seizures, coma, increased bilirubin, renal failure, and finally, death.

"Kratom use has been associated with a variety of serious medical outcomes, from seizures and coma in adults to severe withdrawal syndrome in newborns," said study co-author Henry A. Spiller, MS, DABAT, director, Central Ohio Poison Center at Nationwide Children's Hospital. "Individuals who choose to use kratom need to be aware of the potential risks. Just because it is currently classified as an herbal supplement does not mean it is regulated or that it is safe."

Spiller and colleagues have called for regulation of kratom by the FDA to ensure product uniformity.

Efforts and warnings from the DEA, CDC, FDA

Serious concerns about the toxicity of kratom and its possible links to death have been raised by the FDA. According to the FDA, 44 deaths have been associated with the use of kratom.

Kratom has also been banned in several states—where it is classified as a Schedule I substance—including Alabama, Arkansas, Indiana, Tennessee, Vermont, and Wisconsin, as well as the District of Columbia. Kratom is also banned in Sarasota County, FL, San Diego County, CA, and Denver, CO.

The FDA issued a public health advisory about the deadly risks associated with the use of kratom in November 2017 and then again in February 2018. On February 6, 2018, the FDA published a statement that the use of kratom for medical purposes is not supported by scientific data, and it should not be used as an alternative to prescription opioids, or for opioid withdrawal.

On February 20, 2018, the CDC reported that it was investigating an outbreak of 28 salmonella infections in 20 states that was linked to the use of kratom. Although no deaths were reported, 11 people had been hospitalized with salmonella illness linked to kratom after consuming it in pill, powder, or tea form.

In October 2017, the Department of Health & Human Services recommended to the DEA that mitragynine and 7-OH-mitragynine be “permanently controlled in Schedule I of the [Controlled Substances Act].” The recommendation is supported by the FDA and the National Institute on Drug Abuse.

Although the DEA had planned to add kratom to Schedule I of the Controlled Substances Act, its most restrictive classification “to avoid an imminent hazard to public safety,” this scheduling has not yet happened. Kratom is currently under DEA review.