FDA Warns of Herb Kratom's Opioid-Like Harms

Ilana Panich Linsman for STAT

The Food and Drug Administration issued a public health advisory Tuesday about the use of kratom, a herbal supplement known to ease the side effects of opioid withdrawals that's linked to 36 deaths.

Kratom, which is a naturally growing plant in Thailand, Malaysia, Indonesia and Papua New Guinea, is increasingly being used to treat pain, anxiety, depression and opioid addiction in the United States, at a time when the country is already battling an ongoing opioid epidemic.

The herb gives its users a euphoric feeling when used recreationally, but it's also proven to be just as addictive and, in some cases, deadly as opioids. Between 2010 and 2015, kratom-related calls to US poison control centers jumped 10-fold.

"There's clear data on the increasing harms associated with kratom". Some marketers are promoting kratom as a safe treatment since.

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.

Tablets of the opioid-based Hydrocodone at a pharmacy in Portsmouth, Ohio, June 21, 2017. But it's now taken as a recreational drug, with its users saying it treats anxiety, depression and opioid withdrawal.

But the FDA said Tuesday that kratom carries similar risks, including addiction and death, and the agency is working to block shipments.

Still, Jessica Bardoulas of the American Osteopathic Association said many "were dismayed to learn of the DEA's plan to classify the plan as a Schedule 1 substance. despite anecdotal and scientific evidence indicating kratom could be an effective opioid alternative".

These two uses are what Gottlieb appears to see as the most troubling. "Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee, and Wisconsin and several others have pending legislation to ban it", Gottlieb stated. "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". Last year, the Drug Enforcement Administration stepped back from taking action pending an FDA review. Until someone does the science the agency is requesting, the FDA will attempt to prevent shipments of kratom from entering the US.

Dozens of web sites sell kratom, but the FDA said it would exercise its jurisdiction over the product as an unapproved drug.

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