March 17, 2018

What Is Kratom? Opioid Alternative Poses 'Deadly Risks,' FDA Warns

15 November 2017, 02:07 | Winifred Adams

The FDA is aware of 36 deaths linked to the use of products containing kratom. "Before it can be legally marketed for therapeutic uses in the US, kratom's risks and benefits must be evaluated as part of the regulatory process for drugs that Congress has entrusted the FDA with". Gottlieb says the FDA plans to work with the DEA to determine how kratom should be classified. Between 2010 and 2015, kratom-related calls to US poison control centers jumped 10-fold.

The supplement, kratom, is made from a plant native to Southeast Asia.

But it may be laced with other substances, such as opioids like hydrocodone, the FDA says.

These two uses are what Gottlieb appears to see as the most troubling. The agency states, however, that there is no reliable evidence that kratom can be used to treat opioid use disorder. Users have opposed efforts to regulate the plant, saying it could be a safer alternative to opioid pain pills.

The FDA's chief, Scott Gottleib, asked Congress for more power and expanded resources to combat the opioid epidemic on Tuesday. But the DEA almost made kratom a Schedule 1 drug, the same as heroin and marijuana, last year, and the FDA is now trying to stop shipments of kratom from entering the United States while it works on increasing regulatory oversight. It is also often used recreationally for its euphoric effects.

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Since then, there have been reports of 36 deaths linked with the use of products containing kratom; it can cause serious side effects including seizures and liver damage, and can even trigger symptoms of withdrawal when use is stopped, according to the FDA. The agency has already detained hundreds of packages at global mail facilities.

FDA commissioner Scott Gottlieb released a statement on Tuesday warning people to stay away from the herb.

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

Kratom is banned in Australia, Malaysia, Myanmar, and Thailand and in several USA states - Alabama, Arkansas, Indiana, Tennessee, and Wisconsin. "To those who believe in the proposed medicinal uses of kratom, 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". Until someone does the science the agency is requesting, the FDA will attempt to prevent shipments of kratom from entering the US. "In the meantime, based on the weight of the evidence, the FDA will continue to take action on these products in order to protect public health", Gottlieb said in the statement.

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