The U.S. Food and Drug Administration on Tuesday issued an advisory about harms tied to kratom - an imported herbal supplement with opioid-like effects that is increasing in popularity.
The kratom plant grows naturally across Southeast Asia in the countries of Thailand, Malaysia, Indonesia and Papua New Guinea. It's taken recreationally for its euphoric effects, as a dietary supplement, to treat anxiety and depression, and more. Between 2010 and 2015, kratom-related calls to USA poison control centers jumped 10-fold.
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. "It's probably easier to "do it yourself" with kratom ordered over the internet than find - if it's available - and pay for FDA approved, doctor supervised treatment".
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Since then, there have been reports of 36 deaths linked with the use of products containing kratom; it can cause serious side effects including seizures and liver damage, and can even trigger symptoms of withdrawal when use is stopped, according to the FDA.
In some cases reported to the FDA, kratom is laced with opioids like hydrocodone (Vicodin), Gottlieb noted.
But the FDA said Tuesday that kratom carries similar risks, including addiction and death, and the agency is working to block shipments.
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Previous year the Drug Enforcement Administration planned to make kratom a Schedule I drug, a category that includes marijuana and LSD, but decided against it after an outcry of opposition. The FDA says that review is underway. "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 from taking hold". Anita Gupta, an osteopathic anesthesiologist and licensed pharmacist, has expressed concern about an increase in the use of kratom among her chronic pain patients.
Kratom is already a controlled substance in 16 countries worldwide and is also banned in states such as Alabama, Arkansas, Indiana, Tennessee and Wisconsin. The agency states, however, that there is no reliable evidence that kratom can be used to treat opioid use disorder. Hundreds of shipments have been detained and product has been seized and destroyed.
"I want to be clear on one fact: there are now no FDA-approved therapeutic uses of kratom", Gottlieb wrote.
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Dozens of web sites sell kratom, but the FDA said it would exercise its jurisdiction over the product as an unapproved drug.