A pill that's been credited with delivering super-human strength, feelings of euphoria, powerful pain relief, and better focus has now been linked with 44 deaths.
"We recently conducted a novel scientific analysis using a computational model developed by agency scientists, which provided even stronger evidence of kratom compounds' opioid properties", FDA Commissioner Scott Gottlieb, M.D., said in a statement.
Grundmann: At low concentrations, if you take it you get more of a stimulant effect; in higher concentrations you get more of an analgesic, opioid-like effect.
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A new analysis by scientists at the FDA shows that compounds in kratom, a Southeast Asian tree leaf, act like prescription-strength opioids.
"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", Gottlieb said. I am a proponent of regulating kratom as limiting the excess, as controlling products that are entering the United States [to ensure] they show quality, that there is actually kratom inside when kratom is mentioned on the label.
Despite failing to ever gain FDA approval, kratom has continued to be available for sale online and in stores - including inside a vending machine in Arizona.
Kratum, an herbal supplement, is being used as an alternative to opiate painkillers and heroin and to treat chronic pain, anxiety and depression. Those receptors also have been implicated in the addiction process. It is being touted as a "non-opioid" alternative to traditional opioids. This may lead to adulteration and overdosage on self-medication, says the FDA. "And claiming that kratom is benign because it's "just a plant" is shortsighted and unsafe".
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Gottlieb added in his statement that kraton has a potential for "abuse, addiction, and serious health consequences; including death". Reports of the eight new cases are also to be rel;eased shortly, he said. These were all illicit and harmful drugs. This is the main psychoactive substance that is present in kratom. Based on this definition, compounds in kratom are opioids, because they do act on opioid receptors, said Wes Hunter, director of pharmacy at UCHealth Yampa Valley Medical Center in Steamboat Springs, Colorado. At that time, the FDA noted 36 kratom-related deaths nationwide.
"Many of the cases received could not be fully assessed because of limited information provided", Gottleib said, adding, "a few cases raise concern that kratom is being used in combination with other drugs".
Kratom is now legal under federal law, but FDA inspectors have been seizing and destroying shipments at worldwide mail facilities for months.
The FDA has submitted its review to the DEA, which has not yet said whether it will escalate kratom's listing from "drug of concern" to a Schedule I substance.
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