Concerns About Kratom Prompt Statement from FDA Commissioner

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.

The supplement, kratom, is made from a plant native to Southeast Asia. Between 2010 and 2015, kratom-related calls to USA poison control centers jumped 10-fold. "At a time when we have hit a critical point in the opioid epidemic", the FDA statement said, "the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning". "Calls to US poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year", said FDA Commissioner Dr. Scott Gottlieb in a statement. The FDA is aware that individuals have been using kratom to treat pain, anxiety, and depression, as well as for recreational purposes for its euphoric effects. (A representative from the association could not be reached on Tuesday.) STAT reporter Eric Boodman even found a kratom vending machine in a sub shop in Arizona.

Instead, he said, the FDA is concerned that the use of kratom could actually "expand the opioid epidemic".

In some cases reported to the FDA, kratom is laced with opioids like hydrocodone (Vicodin), Gottlieb noted. 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 asked the FDA to expedite a scientific and medical evaluation and a recommendation for how to handle the compounds in kratom. But for now, no company has tried to properly develop a drug that includes kratom.

In 16 countries, kratom is a controlled substance.

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. The agency has already detained hundreds of packages at worldwide mail facilities. After a public outcry, including letters from members of the House of Representatives and the Senate, the DEA withdrew its intent make it Schedule I. Instead, it opened a public comment period to react to possible scheduling, which closed in December 2016. "Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits".

"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", said Gottlieb in his prepared remarks.

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