By Pat Anson, PNN Editor

The herb kratom poses a public health threat and should not be sold as a dietary supplement, according to a team of researchers who say kratom should be regulated like a prescription drug because it has “opioid-like” qualities.

"Although it is not as strong as some other prescription opioids, kratom does still act as an opioid in the body," said William Eggleston, PharmD, a professor of pharmacy practice at Binghamton University in New York. "In larger doses, it can cause slowed breathing and sedation, meaning that patients can develop the same toxicity they would if using another opioid product.

“Our findings suggest kratom is not reasonably expected to be safe and poses a public health threat due to its availability as an herbal supplement.”

Eggleston is lead author of a recent study published in the journal Pharmacotherapy that looked at the growing number of calls about kratom to U.S. Poison Control Centers. In recent years, millions of Americans have discovered kratom and use it to self-treat chronic pain, addiction, anxiety and depression.

Eggleston and his colleagues identified 2,312 kratom exposures in the National Poison Data System (NPDS) from 2011 to 2018, with 935 cases involving kratom as the only substance.

The chief complaint for many of the calls was that kratom caused agitation, tachycardia (rapid heartbeat), drowsiness, vomiting and confusion. Infrequent but serious side effects included seizure, withdrawal, hallucinations, respiratory depression, coma, and cardiac or respiratory arrest.

‘Significant Toxicity’

“Despite kratom’s growing popularity as a safe and natural self-treatment option for patients with OUD, our findings suggest there are concerns for significant toxicity. Reports of kratom exposures to the NPDS are rising and have already been associated with serious opioid toxicities, including seizures, agitation, and death,” researchers reported.

“According to the United States Dietary Supplement Health and Education Act of 1994, herbal and dietary supplements must contain ingredients that are reasonably expected to be safe. Our findings repudiate the idea that kratom meets this criterion. Kratom’s opioid effects put patients at risk for withdrawal, respiratory depression, and death.”

But critics say calls to poison centers are anecdotal, misleading and a poor choice for research.

“The data drawn from the Poison Control Centers are notoriously unreliable, inasmuch as they are anecdotal reports from the public that are gathered and reported in an unscientific fashion,” said Max Karlin, a spokesman for the Kratom Information & Resource Center. “In the absence of good data, you just end up with a garbage-in, garbage-out situation.”

“All the Eggelston paper shows is that the anti-kratom bias is deeply entrenched in conventional medical, pharmacological and government sectors,” said Jane Babin, PhD, a molecular biologist, patent lawyer and consultant to the American Kratom Association (AKA). “It seems to be more of the same unscientific attack on kratom. I don’t see anything in this that warrants their conclusion.

“AKA now estimates that there are 16 million kratom users in the U.S. based on data from Indonesia on how much kratom is exported to the U.S. annually. 2,312 exposures out of 16 million users is a pretty low percentage of users who have anything to report to poison control.”

The 2,312 calls about kratom over an 8-year period pale in comparison to calls about other substances. In the first six months of this year alone, over 13,400 calls were made to U.S. poison centers about children ingesting hand sanitizers or laundry detergent packets.

Kratom Scheduling

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. As a dietary supplement, kratom is loosely regulated in the United States, although federal agencies are engaged in a protracted public campaign against its use.

The FDA says kratom is addictive, has opioid-like qualities and is not approved for any medical condition. The agency has also released studies showing salmonella bacteria and heavy metals contaminating a relatively small number of kratom products. 

The CDC recently linked kratom to dozens of fatal overdoses -- although multiple substances were involved in nearly all of those deaths.

The Department of Health and Human Services (HHS) has recommended to the DEA that kratom be classified as a Schedule I controlled substance – alongside heroin and marijuana — which would effectively ban it nationwide.

“At some level, we do need to have better control over it,” says study co-author Lewis Nelson, MD, a Professor of Emergency Medicine at Rutgers New Jersey Medical School. “We know that (kratom) has two big uses out there. One of them is for people to get high and the other one is to treat opioid withdrawal. Those are the real reasons people use it.

“Whether its an opioid or not an opioid, people use it do things that they would typically do with opioids, like pain, get high, and treat withdrawal. I think empirically we know it has enough of an opioid-like character that it’s being marketed and used that way.”

Lewis said kratom should be scheduled as a controlled substance, but not under Schedule I. He thinks it may be more appropriate to classify kratom as a Schedule II or III drug, where it could still be available by prescription.

“I would like to see that. If they could show this drug has benefits and we could understand and moderate the risk, I don’t see why it couldn’t be used like any other drug,” said Lewis, who is a longtime critic of opioid prescribing.

“Prove it works. Let’s create a safe product and let’s get it appropriately scheduled. Have it available by prescription. I don’t have a problem with that.”

But getting kratom approved by the FDA as a prescription drug would require years of clinical studies. Pharmaceutical companies may be reluctant to fund research on a natural substance that they may not be able to patent. And kratom users, long accustomed to buying it online or in smoke shops, dislike the idea of needing a doctor’s prescription.

In a 2016 PNN survey of over 6,400 kratom users, nearly 98 percent said they wanted kratom to remain available as a dietary supplement.  Over 70 percent said pharmaceutical companies should not be allowed to produce kratom-based drugs.  And nearly three out of four dispute the notion that it’s possible to get high from kratom.  

Lewis remains skeptical that people are not using kratom recreationally and that it should remain on the market as a dietary supplement.  

“I find it a little disingenuous to say we should leave this potentially unsafe drug on the market unregulated, just because some people already use it,” he told PNN.