Kratom, also known as Mitragyna speciosa, is a plant that grows in Thailand, Malaysia, Indonesia, and Papua New Guinea, according to the FDA. The agency said the plant appeared to expose users to the risks of addiction, abuse, and dependence.
- USA health authorities say an herbal supplement promoted as an alternative pain remedy contains the same chemicals found in opioids, the addictive family of drugs at the center of a national addiction crisis.
Hemby also questioned the FDA's use of computer analysis to arrive at its conclusion.
In September 2014, U.S. Marshals, at the FDA's request, seized more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc.in Van Nuys, California. "From this analysis, the agency concluded that all of the compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives", Dr. Gottlieb said.
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The PHASE model predicted that some of the kratom compounds bind to receptors in the brain that could contribute to stress, which impacts neurologic and cardiovascular function, corroborating a previous warning that side effects of kratom could cause seizures and respiratory distress. Federal agencies must move quickly to assess the abuse potential of newly identified designer street drugs for which limited or no pharmacological data are yet available.
"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 information, the FDA said it feels "confident in calling compounds in kratom opioids". The FDA "first put kratom on import alert" in 2012, FDA press officer Lyndsay Meyer told Business Insider in November.
In the advisory released in November, Dr. Gottlieb referenced 36 reported deaths linked to use of kratom-containing products, and cited instances of kratom laced with other opioids like hydrocodone.
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Still, concern about kratom is mounting, especially because some people appear to be using the supplement as a way to step down from opioid painkillers like heroin and morphine. He noted that, "Given all these considerations, we must ask ourselves whether the use of kratom-for recreation, pain, or other reasons-could expand the opioid epidemic".
"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.
"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 healthcare provider".
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