FDA issues strong warning about kratom to treat pain, opioid addiction

FDA raises concerns about use of kratom for opioid addiction

FDA raises concerns about use of kratom for opioid addiction

Kratom also has opioid-like effects - at low doses, it acts like a stimulant; at higher doses, it sedates, dulling pain - which has also made it popular as an over-the-counter remedy for opioid withdrawal.

But in a statement, FDA commissioner Scott Gottlieb said there is no "reliable evidence" to support the use of kratom as a treatment for opioid-use disorder, and that there are no other FDA-approved uses of kratom.

"The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products", said FDA Commissioner Scott Gottlieb, MD, in a November 14 statement. Because it produces symptoms, such as euphoria, similar to opiates, it is also used recreationally. FDA warns that the plant has the same risks of abuse, addiction, and possibly, death. In some cases, kratom is mixed with opioids like oxycodone, the ingredient in OxyContin, according to the agency.

Instead, he said, the FDA is concerned that the use of kratom could actually "expand the opioid epidemic".

Gottlieb pointed to reports of 36 deaths associated with kratom, as well as a tenfold increase in calls to United States poison control centers about the substance between 2010 and 2015.

The regulator said there are now no approved therapeutic uses of kratom, which is linked to serious side effects such as seizures and liver damage.

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In August 2016, the US Drug Enforcement Agency (DEA) drew the ire of thousands when it announced plans to add kratom to its list of schedule I drugs.

FDA has taken action against dietary supplements containing kratom and is working to prevent shipments from entering the country. Hundreds of shipments have already been detained and many are seized. Kratom is already a controlled substance in 16 countries, including two of its native countries of origin, Thailand and Malaysia, as well as Australia, Sweden, and Germany. "Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee, and Wisconsin and several others have pending legislation to ban it", Gottlieb stated.

"FDA must use its authority to protect the public from addictive substances like kratom, both as part of our commitment to stemming the opioid epidemic and preventing another from taking hold".

"While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound-science and weighted appropriately against the potential for abuse", he wrote. They must be put through a proper evaluative process that involves the DEA and the FDA.

"To those who believe in the proposed medicinal uses of kratom", he wrote, "I encourage you to conduct the research that will help us better understand kratom's risk and benefit profile, so that well studied and potentially beneficial products can be considered".

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