FDA Warns Against Using Kratom Products for Opioid Treatment

FDA commissioner Scott Gottlieb speaks to members of the USA TODAY Editorial Board in August 2017

FDA commissioner Scott Gottlieb speaks to members of the USA TODAY Editorial Board in August 2017

"Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed healthcare provider about the product's dangers, potential side effects, or interactions with other drugs", Gottlieb said in the statement. It is used to treat pain, anxiety and depression, with reported effects similar to opioids.

Data show that there is harm associated with the use of kratom. The agency states, however, that there is no reliable evidence that kratom can be used to treat opioid use disorder.

Kratom is a naturally growing plant in Thailand, Malaysia, Indonesia and Papua New Guinea, and is being marketed as a "safe" treatment option for certain diseases, including opioid addiction, the FDA said.

"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", Gottlieb said.

The FDA said it is aware of 36 deaths involving products made with kratom and hundreds of calls to poison control centers, which increased tenfold 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. Today, kratom leaves are ground into pills and powders, and sold as a dietary supplement. It's even made into drinks in some bars. It has this effect because its active ingredients, mitragynine and 7-hydroxymitragynine, bind to the opioid receptors in our body, Boyer said, but unlike opioid drugs such as hydrocodone or heroin, it doesn't appear to slow breathing. Between February 2014 and July 2016, the DEA said, almost 247,000 pounds of kratom were seized.

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". But the agency backed away from that plan last October after a flood of public complaints including a letter signed by 62 members of Congress and a protest at the White House organized by the American Kratom Association. Since that time, the DEA has taken no action.

"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".

Commissioner Scott Gottlieb issued a statement warning about the risks associated with kratom.

Later in 2016, the DEA asked that the FDA provide a scientific and medical evaluation of the drug. "From the outset, the 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".

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