Kratom has 'deadly risks,' FDA warns

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.

Kratom has grown in popularity in the US, with circulating claims of it being a safe treatment with a range of healing properties. It's taken recreationally for its euphoric effects, as a dietary supplement, to treat anxiety and depression, and more.

The herbal product has been shown to exert similar effects as opioids, carrying with it similar risks of abuse and addiction.

Kratom also has opioid-like effects - at low doses, it acts like a stimulant; at higher doses, it sedates, dulling pain - which has also made it popular as an over-the-counter remedy for opioid withdrawal.

Meanwhile, a similarly troubling trend has been seen with kratom. The FDA is devoted to expanding the development and use of medical therapy to assist in the treatment of opioid use disorder. The FDA noted a 10-fold increase in calls made to US poison control centers regarding kratom from 2010 to 2015, and reports of 36 deaths linked to the substance.

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

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The FDA's chief, Scott Gottleib, asked Congress for more power and expanded resources to combat the opioid epidemic on Tuesday. The agency also has a team of medical reviewers in the FDA's Center for Drug Evaluation and Research that's dedicated to the proper development of drug applications for botanicals. Gottlieb says the FDA plans to work with the DEA to determine how kratom should be classified.

If companies want to market kratom for its supposed health benefits, they should go through the FDA's drug review process, Gottlieb said.

In 2014, the FDA issued an alert that allowed USA officials to detain kratom without a physical examination.

"This is especially relevant given the public's perception that it can be a safe alternative to prescription opioids", he added.

Meanwhile, the FDA is working to prevent shipments of kratom from entering he country, he said. We've used our authority to conduct seizures and to oversee the voluntary destruction of kratom products. 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. Some products have unsafe substances other than kratom in them, including opioids.

"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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