The FDA Says Kratom Is an Opioid: Now What?

/The FDA Says Kratom Is an Opioid: Now What?

“Further, as the scientific data and adverse event reports have clearly revealed, compounds in kratom make it so it isn’t just a plant – it’s an opioid. And it’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms.”

~ Dr. Scott Gottlieb, M.D., Commissioner of the Food and Drug Administration, in a press release

In early February 2018, the FDA declared that kratom, a popular herbal supplement, should be treated as an opioid that is not “safe or effective for any medical use”.

While kratom users and supporters are protesting this declaration, the FDA insists that its decision is entirely based on sound scientific testing and established standards of drug classification and scheduling.

What Is Kratom?

Kratom—scientific name mitragyna speciosa—is a plant native to Southeast Asia, where it is commonly used in folk healing. Traditionally, it is used medicinally to:

  • Reduce pain
  • Stimulate the appetite
  • Suppress coughing
  • Relieve diarrhea
  • Treat intestinal infections

But kratom is also abused recreationally, because it produces several pleasurable effects, including:

  • Increased energy
  • Euphoria
  • Excitement
  • Mood enhancement
  • Greater sociability
  • Sexual desire

In the United States, kratom has been sold as an herbal supplement marketed as a “natural, safe, and illegal” alternative to more dangerous substances – opioids like prescription painkillers and heroin, and stimulants like cocaine and methamphetamine.

Supporters of kratom use say that it is a safe way to self-treat opioid addiction. In fact, almost 70% of Americans who use kratom do so to alleviate symptoms of opioid withdrawal.

But even among supporters there are those urging caution.

Dr. Christopher R. McCurdy, PhD, a medicinal chemistry professor with the University of Florida’s College of Pharmacy, says “I definitely believe there is a legitimacy for using kratom to self-treat an opiate addiction. I believe it from the standpoint of the material we know is pure and unadulterated and good. I just don’t know if all products available are consistently pure and good.”

Kratom in Other Countries

In this way, kratom abuse in Southeast Asia is similar to that of khat in Africa and coca in South America. As a result, kratom is illegal or controlled in several countries, including:

  • Australia—illegal, treated as a narcotic
  • Burma—illegal
  • Canada—illegal to market kratom as safe for ingestion
  • Denmark—controlled
  • England—the import, export, and sale of kratom is illegal
  • Finland—controlled and available by prescription only; illegal to import
  • Germany—controlled as an unlicensed medicine
  • Ireland—imports are subject to seizure
  • Latvia—controlled
  • Lithuania—controlled
  • Malaysia—illegal
  • Myanmar—illegal
  • New Zealand—controlled and available by prescription only; import and export are prohibited
  • Poland—controlled
  • Romania—illegal
  • Sweden—controlled
  • South Korea–illegal
  • Thailand—illegal

In fact, to combat the problem of rampant kratom abuse, Thailand occasionally conducts eradication programs to destroy forests where the trees grow.

The Rocky History of Kratom in the US

“We have identified kratom as a botanical substance that poses a risk to public health and has the potential for abuse. This action was taken to safeguard the public from this dangerous product, and FDA will continue to take aggressive enforcement actions against products that are promoted for uses that are unapproved.”

~ Melinda Plaisier, Associate Commissioner for Regulatory Affairs, FDA

While this announcement from the FDA may cause some dismay to the up to 5 million kratom users in the United States, this determination is not exactly unexpected. Right from the start, kratom has had a problematic existence in this country.

  • 2012: The FDA issued an “Import Alert” about kratom.
  • 2014: Shipments of imported kratom were seized by the FDA. Although it was marketed as a dietary supplement and sold openly at convenience stores, truck stops, and head shops, there were concerns about its safety.
  • 2016: Despite public outcry from users and pressure from some members of Congress, the Drug Enforcement Administration announced in August plans to classify kratom as a Schedule I controlled substance, for three stated reasons. Kratom:
    • Has a high potential for abuse
    • No currently-accepted medical application in the US
    • No scientifically-verifiable safety record

About the outcry and pressure, a DEA spokesperson said, “We can’t rely upon public opinion and anecdotal evidence. We have to rely upon science.”

However, by October, those scheduling plans were postponed, pending further review.

  • 2017: Because of concerns about misleading marketing and dangerous side effects – including deaths – the FDA made an announcement:

“There is no reliable evidence supports the use of kratom as a treatment for opioid use disorder; there are currently no FDA-approved therapeutic uses of kratom… and the FDA has evidence to show that there are significant safety issues associated with its use.”

2018: A New Determination – Kratom IS an Opioid

“Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids.”

~ Dr. Scott Gottlieb

One of the major reasons that kratom has had such a contentious time gaining approval is due to the fact that there is a decided dearth of scientific studies involving either its safety or its efficacy among humans.

Part of the job of the FDA is to evaluate the abuse potential of new substances for which there is little to no established pharmacological data. This would include kratom, other dietary supplements, and so-called “designer drugs”.

Obviously, such evaluations need to happen quickly.

To aid in this, the FDA developed what it calls the PHASE method – the Public Health Assessment via Structural Evaluation. This is a tool that uses 3-D computer technology to simulate the molecular structure of the chemical components of any substance.

Of special relevance, the PHASE model can simulate how these substances and compounds behave within the user’s body. Specifically, it can use a substance’s chemical structure to predict how the brain will be affected.

Here’s the thing – the FDA looked at the 25 most-prevalent compounds found in kratom. Chemical analysis determined that ALL of these compounds were structurally similar to opioids. Even more significant, 22 of the 25 compounds bind to the brain’s opioid receptors, and two out of the top five actually activate those receptors.

But that’s not all – kratom strongly binds to those receptors, to a degree roughly equivalent to already-identified and controlled opioid drugs.

Furthermore, the analysis also predicts that kratom compounds cause similar neurologic and cardiovascular effects as opioids – respiratory depression, for example.

Are There Any Other Concerns about Kratom?

…cases with fatal outcomes raise concern that kratom is being used in combination with other drugs that affect the brain, including illicit drugs, prescription opioids, benzodiazepines, and over-the-counter medications…”

~ Dr. Scott Gottlieb

Based on the FDA’s PHASE model, the most obvious concern should be the risk of kratom overdose, especially when it is used in combination with other substances. Since 2011, dozens of deaths have been linked to the use of kratom.

But one of the biggest problems with kratom is the fact that it is primarily imported from countries where there is very little regulatory oversight. In other words, there is virtually no way for a person to know what is actually in the kratom they are taking. This is especially true for online kratom purchases.

Case in point – in late February 2018, the Centers for Disease Control and Prevention reported that kratom is behind a salmonella outbreak that has spread across 27 states so far, sickening dozens of people. Although no deaths have yet been reported, more than half of the victims have been hospitalized.

And, because the outbreak cannot be traced to a single brand, the CDC recommends that people stay away from ALL pills, powders, and teas containing kratom.

Is Kratom REALLY a Treatment for Opioid Addiction?

“It’s preying on the weak and the broken. It’s a mind-altering substance, so people like me who are addicts and alcoholics, they think just because it’s legal, it’s fine. It’s a huge epidemic down here, and it’s causing a lot of relapses.”

~ Dariya Pankova, a recovering heroin addict who used kratom and relapsed

Contrary to the marketed reputation that it is a benign natural substitute for dangerous opioids, kratom is itself addictive. Even worse, because it affects the same areas of the brain as more dangerous opioids, it can prime an addict’s brain for a relapse.

In fact, once a person gets used to the high provided by kratom, they may switch back to heroin for practical reasons – heroin is cheaper and stronger than kratom. Those are powerful motivations for a struggling junkie.

Dr. Edward W. Boyer, and Emergency Medicine Professor at the University of Massachusetts Medical School, who has written extensively about kratom, says, “Recreationally or to self-treat opioid dependence, beware — potentially you’re at just as much risk…

So What Happens Now?

From the outset, the FDA must use its authority to protect the public from addictive substances like kratom, both as part of our commitment to stemming the opioid epidemic and preventing another one from taking hold.”

~Dr. Scott Gottlieb

Since the FDA has submitted its declaration, the decision is now in the hands of the DEA. While kratom isn’t exactly disappearing from store shelves (yet), and while it still widely available on the Internet, some supplement companies have already voluntarily suspended kratom sales.

To anyone using – or even considering using – kratom, there are some cautionary takeaways:

FIRST, kratom is not as safe as it is reputed to be. The verifiable risks include:

  • Dependence/Addiction
  • Seizures
  • Overdose, especially when combined with other drugs
  • Impurities/Poisoning
  • Opioid relapse

SECOND, if someone is currently self-medicating with kratom as a substitute for heroin or abused painkillers, and if that kratom becomes classified as a controlled or banned substance, it could immediately push them right back into active addiction.

What should be done?

If you or someone you care about is struggling with a dependence on or addiction to ANY opioid – including kratom – the best medically-established treatment protocol is specialized addiction therapy, combined with FDA-approved anti-craving medications.

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By | 2018-04-07T00:33:00+00:00 April 6th, 2018|

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