Published: Wed, November 15, 2017
Medicine | By Brett Sutton

FDA Warns About Dangers Of 'Natural' Opioid Kratom

FDA Warns About Dangers Of 'Natural' Opioid Kratom

"There's clear data on the increasing harms associated with kratom".

Past year the Drug Enforcement Administration planned to make kratom a Schedule I drug, a category that includes marijuana and LSD, but decided against it after an outcry of opposition. Between 2010 and 2015, kratom-related calls to USA poison control centers jumped 10-fold.

Leaves from the kratom tree, which grows in Southeast Asia and is distantly related to coffee plants, have been touted as a potential treatment for opioid withdrawal, among other conditions.

"It's very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms", FDA Commissioner Scott Gottlieb said in a statement, adding that not only is there no reliable evidence that kratom is an effective treatment for opioid use disorder, there are FDA-approved medications that work.

In this photo illustration, capsules of the herbal supplement Kratom are seen on May 10, 2016 in Miami, Florida.

The drug is kratom, and despite failing to gain FDA approval, it continued to be available for sale online and in stores - including inside a vending machine in Arizona.


Because kratom is largely unregulated, "you never know the real strength, ingredients, or how it's prepared", says Chris Barth, who used the medication Suboxone to recover from a pain pill addiction a decade ago. It's also increasingly being used to treat opioid withdrawals, states the FDA, which warns of liver damage, seizures, addiction, and death. Additionally, the FDA is aware of reports of 26 deaths associated with the use of kratom-containing products, and that there have been reports of kratom being laced with other opioids like hydrocodone.

"There are now no FDA-approved therapeutic uses of kratom", said Gottlieb.

"Given all these considerations, we must ask ourselves whether the use of kratom-for recreation, pain or other reasons-could expand the opioid epidemic". The DEA will review the FDA's assessment and make a determination, says DEA spokesperson Wade Sparks.

"I want to be clear on one fact: there are now no FDA-approved therapeutic uses of kratom", Gottlieb wrote. Instead, Gottlieb mentioned that kratom is already a controlled substance in 16 countries, and that several states have pending legislation to ban it. Hundreds of shipments have been detained and product has been seized and destroyed.

"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.

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