Along with its latest statement on kratom, the FDA released details of the case reports in which kratom was implicated in 44 deaths.
"I want to be clear on one fact: there are now no FDA-approved therapeutic uses of kratom", Gottlieb said.
"We recognize the need and desire for alternative treatments for both the treatment of opioid addiction, as well as the treatment of chronic pain".
From this analysis, the researchers concluded that all of the substance's compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.
However, the American Kratom Association (AKA), a vocal advocate for the drug, calls the FDA's assessment "utterly and completely wrong", comparing it to a trick play to pressure the DEA into banning the substance. Their new model, together with previously available experimental data, confirm that two of the top five most prevalent compounds (including mitragynine) are known to activate opioid receptors ("opioid agonists").
Gottlieb said the FDA has been especially concerned about kratom's use to treat opioid withdrawal symptoms, and warned against it.
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"Cases of mixing kratom, other opioids and other types of medication is extremely troubling because the activity of kratom at opioid receptors indicates there may be similar risks of combining kratom with certain drugs, just as there are with FDA-approved opioids", Gottlieb said.
Based on the new FDA new research, along with information from previous studies and reports of harmful effects tied to kratom, "we feel confident in calling compounds found in kratom, opioids", Gottlieb said in a statement.
In addition to being marketed as a concentration booster and workout enhancer in largely unregulated supplements, kratom has been advertised as a replacement for opioid painkillers. For example, calls to poison centers regarding kratom increased tenfold between 2010 and 2015, rising from 26 to 263, according to the U.S. Centers for Disease Control and Prevention.
Gottlieb said that kratom was used to treat pain, anxiety, and depression-and was also being taken recreationally because its effects somewhat mimicked that of more powerful processed opiates. At least one of the chemicals may also have some addictive properties.
The FDA conducted a scientific analysis using a computational model developed by agency scientists, he said.
"For individuals seeking treatment for opioid addiction who are being told that kratom can be an effective treatment, I urge you to seek help from a health care provider", Dr. Gottlieb added. "Just because it binds, it doesn't mean it has the same efficacy" as an opioid, Hemby added. "People would find that unacceptable".