FDA Warns Against Use of Kratom to Treat Opioid Addiction

The Food and Drug Administration has issued a warning on the “deadly risks” associated with the use of kratom, an herbal supplement touted as a treatment for anxiety and depression and more recently as an alternative to opioid pain pills. What’s more, individuals who have become addicted to opioids are now using kratom as a do-it-yourself detox, which one addiction expert called a highly dangerous, even fatal proposition. “The unregulated and unsupervised use of kratom for treating opioid dependence is a disaster waiting to happen,” said David Sack, MD, chief medical officer at Elements Behavioral Health. “There is no science behind it, no controlled studies with large groups of people with controlled dosing. So it’s impossible to be confident about the concentration of the leaves, the strength of the tea, the dosing for a specific problem. Those are real issues.” It’s important to note that kratom is addictive in its own right. People vary in their genetic susceptibility to addiction, and those who have such a risk are in danger of developing a dependence on kratom, Dr. Sack said. In fact, FDA Commissioner Scott Gottlieb fears that the use of kratom could actually “expand the opioid epidemic,” which has been blamed for more than 59,000 deaths in 2016 alone.

What Is Kratom?

Kratom comes from an evergreen tree, the Mitragyna speciosa, that grows naturally in parts of Asia. The substance is not an opioid — kratom is actually in the coffee family — but it acts like one. Its leaves have been used for centuries to increase energy, enhance mood and relieve pain. The leaves can be eaten raw, but are more commonly ground into a powder and turned into capsules or mixed into teas, protein shakes and yogurt.

Kratom Deaths

In issuing its advisory on kratom, the FDA pointed to 36 deaths linked to the supplement, as well as a 10-fold increase in the number of calls to poison control centers from 2010 to 2015 about problems stemming from its ingestion. Among the victims were:

  • A 36-year-old man who was rushed to a hospital after suffering a grand mal seizure and soon declared brain dead.  His cause of death was listed as “apparent acute mitragynine toxicity.” (Mitragynine is the most abundant organic compound in kratom.)
  • A 27-year-old who died due to bleeding in his lungs. The autopsy report said he had a “hemorrhagic pulmonary edema due to kratom overdose.”
  • Another 27-year-old man had a muscle relaxer, an antidepressant and kratom in his system when he died, according to the autopsy.

The case of the man who had ingested multiple substances points to the danger of combining kratom with medications. Kratom interferes with other drugs that work on the serotonin system, according to Dr. Sack, who said that someone who is being treated for depression or anxiety, or with mood stabilizers for bipolar disorder, is at a much higher risk for serious, life-threatening complications when trying to manage opioid cravings by themselves with kratom.

Is Kratom Legal?

Kratom can be sold legally everywhere in the U.S. except Alabama, Arkansas, Indiana, Tennessee and Wisconsin. Last year, the U.S. Drug Enforcement Administration tried to ban kratom by classifying it as a Schedule 1 drug, lumping it in with heroin, LSD and ecstasy, but withdrew the plan due to an outcry from such groups as the American Kratom Association and the Botanical Education Alliance.

Why Do People Use Kratom?

Advocates say kratom provides relief from not only pain, but also anxiety and depression.  Many individuals use it purely for recreational purposes, saying it makes them feel more social and alert. “It causes euphoria and relaxation not unlike opioid medications,” Dr. Sack said. “It doesn’t have the same chemical structure as opioids, but it binds to the same receptor sites in the brain.” As for self-detox, Dr. Sack says the people addicted to Vicodin, OxyContin or even heroin (although kratom is not potent enough to detox from heroin, he adds) who are looking for a way to come off of their addiction without having to go for treatment and without having to work with a doctor are setting themselves up for failure. Depending on the intensity of their addiction, it may take a lot of kratom. And if it takes a lot of kratom, there will be side effects, which could include liver damage, seizures and withdrawal symptoms.  However, there’s much more to it than that. “What we know about addiction treatment is that detox is not a treatment,” Dr. Sack said. “People who only go through detox and don’t receive comprehensive psychosocial services and support, are, for all intents and purposes, no better off in a year.  So the notion that you can treat yourself with kratom and detox really doesn’t lead to anything else if you don’t get more help.  It just leads to relapse.” And we know from the exploding opioid epidemic that opioid relapses after detox are more likely to be fatal because the user’s tolerance is down. “Detox alone, without a treatment plan, just increases your risk of dying of an overdose,” Dr. Sack said.

Kratom Withdrawal Symptoms

Individuals who develop an addiction to kratom report withdrawal symptoms similar to those of opioids. The symptoms include:

  • Hostility
  • Irritability
  • Aggression
  • Insomnia
  • Severe depression
  • Anxiety
  • Muscle aches
  • Flu-like symptoms

Psychotic and dissociative symptoms can also occur during kratom withdrawal, although they are usually not severe. However, in about one-third of the cases, the psychosis is persistent and requires treatment.

Looking Ahead

As of today, there are no FDA-approved uses for kratom. But it’s not that there will never be a therapeutic use for the substance, Dr. Sack says. Rather, it’s that the current use is neither safe nor predictable. If you look at how treatment for opioid dependency works, if you’re using buprenorphine or methadone as a maintenance treatment, you’re basically substituting them for the drug of abuse, Dr. Sack said. And because they don’t get you as high, and because buprenorphine is significantly safer, they allow a person to engage in psychosocial rehab and psychotherapy that hopefully gets them better over time. “You might argue that there are people who have done poorly on the existing treatment who might benefit,” he added. “But the truth is that most people haven’t had adequate trials of those treatments, so before you can get to something like kratom and say this is God’s gift, one would have to be confident that they hadn’t done well in established treatments.” Sources: Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom Federal Register: Schedules of Controlled Substances: Temporary Placement of Mitragynine and 7-Hydroxymitragynine Into Schedule I Centers for Disease Control and Prevention: Notes from the Field: Kratom (Mitragyna speciosa) Exposures Reported to Poison Centers — United States, 2010–2015 Kratom: Herbal supplement or dangerous drug?

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