FDA raises concerns about use of kratom for opioid addiction

Leslie Hanson
November 14, 2017

TUESDAY, Nov. 14, 2017 (HealthDay News) - The U.S. Food and Drug Administration on Tuesday issued an advisory about harms tied to kratom - an imported herbal supplement with opioid-like effects that is increasing in popularity.

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. "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 statement. "The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms", Gottlieb noted.

The health risks associated with kratom have also been clearly established as seen with a 10-fold increase (from 2010 to 2015) in calls to USA poison control centers regarding its use. Proponents say it is a safe way to deal with chronic pain and other ailments, and some researchers are exploring its therapeutic potential, including helping people overcome addictions. Jessica Bardoulas of the American Osteopathic Association tells USA Today there's "anecdotal and scientific evidence indicating kratom could be an effective opioid alternative".

The FDA's warning comes a little over a year after the Drug Enforcement Administration backtracked on its plans to move kratom to the Schedule 1 drug list.

The FDA says it's aware of 36 deaths linked to kratom, as well as a tenfold increase in calls to USA poison control centers about the substance between 2010 and 2015. Before it can be legally marketed for therapeutic uses in the USA, kratom's risks and benefits must be evaluated as part of the regulatory process for drugs that Congress has entrusted the FDA with. Others use kratom for its euphoric effects, or to wean addicts off opioids such as prescription painkillers or heroin, also without medical say-so. But for now, no company has tried to properly develop a drug that includes kratom. Until someone does the science the agency is requesting, the FDA will attempt to prevent shipments of kratom from entering the US.

The FDA said it is working to prevent shipments of kratom in the United States and has detained hundreds of these packages at global mail facilities. 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.

The herb is banned in several states, such as Indiana, Tennessee, Alabama, Arkansas and Wisconsin.

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. Since that time, the DEA has taken no action.

Other reports by Iphone Fresh

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