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FDA issues strong warning about kratom to treat pain, opioid addiction
14 November 2017, 10:40 | Silvia Roy
FDA Issues Warning Against Kratom, A Naturally Occurring but Unapproved Plant
Kratom is a plant native to Southeast Asia, and Americans are increasingly using it to treat pain, anxiety, depression and the symptoms of opioid withdrawal.
The FDA's cautioning comes after the Drug Enforcement Administration's delay in listing kratom, a plant found in countries like Thailand and Malaysia, as a controlled substance.
In a public health advisory released Tuesday, the FDA commissioner said kratom has similar effects to narcotics like opioids. Seizures, liver damage, and withdrawal symptoms have all been associated with kratom use. He said that calls to US poison control centers involving kratom increased 10-fold between 2010 and 2015, and that the herb is associated with side effects including seizures, liver damage and withdrawal symptoms.
Importers, organized crime or others in the supply chain could be part of conspiracies to distribute illegal opioids, Sharfstein says. The warning comes amid an increase in popularity in the USA, where kratom is touted as a treatment for pain, anxiety, depression and even as an opioid alternative.
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In August 2016, the Drug Enforcement Agency moved to make kratom a Schedule I drug, a substance that has "no now accepted medical use and a high potential for abuse".
There have been 36 deaths linked to the use of kratom-containing products, the FDA said, adding that the substance is also being laced with other opioids like hydrocodone for marketing purposes.
"Given all these considerations, we must ask ourselves whether the use of kratom-for recreation, pain or other reasons-could expand the opioid epidemic".
At this time, there are no FDA-approved therapeutic uses of kratom; its risks and benefits must be assessed under the FDA regulatory process before it can be legally marketed for therapy.
So far, no marketer has tried "to properly develop a drug that includes kratom", Gottlieb said. "There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder". Until someone does the science the agency is requesting, the FDA will attempt to prevent shipments of kratom from entering the US.
The FDA has exercised jurisdiction over kratom as an unapproved drug, and has also taken action against kratom-containing dietary supplements. And in the United States, Alabama, Arkansas, Indiana, Tennessee and Wisconsin have banned kratom.
The FDA said it is working to prevent shipments of kratom in the United States and has detained hundreds of these packages at worldwide mail facilities.
We've learned a tragic lesson from the opioid crisis: that we must pay early attention to the potential for new products to cause addiction and we must take strong, decisive measures to intervene.
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