FDA Warns That Kratom May Be Similar To Opioids

FDA Warns That Kratom May Be Similar To Opioids

7, 2018 The popular botanical drug kratom essentially is an opioid, the U.S. Food and Drug Administration declared Tuesday. 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. In at least one case, the person who died had no known historical or toxicologic evidence of opioid use except for kratom.

The FDA developed the Public Health Assessment via Structural Evaluation (PHASE) methodology, which uses 3-D computer technology to simulate the chemical constituents of a substance - like kratom alkaloids - to see how the molecules behave once inside the body.

"We recognize the need and desire for alternative treatments for both the treatment of opioid addiction, as well as the treatment of chronic pain". "Numerous scientific studies, including studied funded by the NIH, have shown the addiction potential for kratom is substantially lower than that of "narcotic-like opioids" and it does not produce the deadly respiratory depressant effects that is the primary cause of opioid overdose deaths".

More than one-third of the poison center calls reported use of kratom in combination with other substances, such as illicit drugs, prescription opioids or over-the-counter medications, the CDC said.

Their analysis also found that some of the kratom compounds may bind to the receptors in the brain that may contribute to stress responses that impact neurologic and cardiovascular function. They also found that 22 of the 25 compounds in kratom bind strongly to mu-opioid receptors, comparable to opioid drugs.

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Now, FDA commissioner Scott Gottlieb has gone a step further by releasing what the agency says is strong evidence that kratom compounds are themselves opioids.

"There is no evidence to indicate that kratom is safe or effective for any medical use and claiming that kratom is benign because it's "just a plant" is shortsighted and unsafe", the FDA said in a statement.

But Gottlieb warned that claiming it's harmless because it's "just a plant" is shortsighted and risky. Gottlieb explained, "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". The agency instead called on the FDA to issue a public comment and scientific review of the plant.

In 2016, the DEA proposed a ban on kratom but backtracked under pressure from some members of Congress and outcry from kratom advocates who said it could help treat opioid addiction. "Just because it binds, it doesn't mean it has the same efficacy" as an opioid, Hemby added. "People would find that unacceptable".