FDA Warns Of Herbal Supplement Kratom Containing Potential Opioid Properties

FDA Warns That Kratom May Be Similar To Opioids

The US Food and Drug Administration warned the public once again on the use of the herbal supplement kratom in a statement on Tuesday. Last year, the agency reported that 36 deaths had been associated with its use, and in yesterday's announcement, Gottlieb updated the figure to 44 deaths.

Kratom is the common name for the plant Mitragyna speciosa, which grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. It has been sold as a dietary supplement to help manage pain and boost energy.

In a statement released on November 14., 2017, FDA Commissioner Scott Gottlieb, M.D., said "kratom has raised significant concerns given its increasing prevalence and potential safety risks".

"There is no evidence to indicate that kratom is safe or effective for any medical use", Gottlieb said, adding that consumers using kratom for pain relief could seek other "safe" non-opioid options.

"There is no evidence to indicate that kratom is safe or effective for any medical use and claiming that kratom is benign because it's "just a plant" is shortsighted and unsafe", the FDA said in a statement. The public health advisory was intended for people who use kratom as an alternative to opioids, due to its similar effects.

"We recognize that many people have unmet needs when it comes to treating pain or addiction disorders", he said.

The Centers for Disease Control and Prevention clocked a tenfold increase in calls regarding kratom to poison control centers, from just 26 in 2010 to 263 in 2015.

In all but one case, the people who died were found to have been taking multiple drugs, including other opioids in many cases. Gottlieb said, "The model shows us that kratom compounds are predicted to affect the body just like opioids".

For their latest report, scientists at the FDA looked at the chemical structures of the 25 most prevalent compounds in kratom. Those receptors also have been implicated in the addiction process. The model predicted that 22 of the 25 compounds in kratom (including mitragynine) bind to mu-opioid receptors.

"This is an unprecedented abuse of science to create a new computer program that is clearly garbage in garbage out avoiding the rules of the Controlled Substances Act and making unproven claims that have been proven to be untrue".

In addition to being marketed as a concentration booster and workout enhancer in largely unregulated supplements, kratom has been advertised as a replacement for opioid painkillers. At least one of the chemicals may also have some addictive properties. "Just because it binds, it doesn't mean it has the same efficacy" as an opioid, Hemby added.

The FDA conducted a scientific analysis using a computational model developed by agency scientists, he said.

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