FDA Warns About 'Deadly Risks' Of Taking Kratom For Opioid Addiction

Alicia Farmer
November 14, 2017

It has been linked with 36 deaths.

The FDA issued a public health advisory on Tuesday over the use of kratom, an unapproved botanical substance that originates from Thailand, Malaysia, Indonesia and Papua New Guinea.

For now, kratom is widely available online and in some stores.

"Evidence shows that kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in some cases, death", FDA commissioner Scott Gottlieb said in a statement.

Along with opioid withdrawal, kratom is also believed to relieve fatigue, pain, cough and diarrhea.

"I understand that there's a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders".

Importers, organized crime or others in the supply chain could be part of conspiracies to distribute illegal opioids, Sharfstein says.

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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. When ingested, the drug taps into some of the same brain receptors as opioids. The warning comes amid an increase in popularity in the US, where kratom is touted as a treatment for pain, anxiety, depression and even as an opioid alternative. Calls to poison control centers regarding kratom have increased 10-fold from 2010 to 2015. But for now, no company has tried to properly develop a drug that includes 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. The herbal supplement is a psychoactive drug derived from the leaves of the kratom plant and it's been reported that people are using the supplement to get high and some states are banning the supplement. Across the USA, several reports of deaths and addiction led the Drug Enforcement Administration to place kratom on its list of "drugs and chemicals of concern".

Gottlieb, who did two previous stints at the FDA, has publicly expressed misgivings about how long it took the agency to truly address the crisis.

"I want to be clear on one fact: there are now no FDA-approved therapeutic uses of kratom", Gottlieb wrote.

However, the FDA is not convinced that kratom belongs in unregulated hands.

In November, researchers at Harvard Medical School and independent product testing company NSF International identified four unapproved, unlisted stimulants in six supplements now marketed for weight loss and fitness.

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