Consumers are increasingly using the supplement, which comes from a plant in Southeast Asia, for pain, anxiety and depression, as well as symptoms of opioid withdrawal. But it has addictive properties of its own, FDA says in a public health advisory related to the FDA's mounting concerns regarding risks associated with the use of kratom.
"The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products", said FDA Commissioner Scott Gottlieb, MD, in a November 14 statement. "It's not surprising that kratom is often taken recreationally by users for its euphoric effects, [however, ] at a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning", he wrote. FDA warns that the plant has the same risks of abuse, addiction, and possibly, death. The agency states, however, that there is no reliable evidence that kratom can be used to treat opioid use disorder.
The group has said categorizing kratom as an illegal substance would stymie medical research into its potential therapeutic uses. In his statement, he wrote that calls to United States poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year.
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Tablets of the opioid-based Hydrocodone at a pharmacy in Portsmouth, Ohio, June 21, 2017. "The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms".
The FDA has exercised jurisdiction over kratom as an unapproved drug, and has also taken action against kratom-containing dietary supplements. Hundreds of shipments have been detained and product has been seized and destroyed.
In August 2016, the Drug Enforcement Agency moved to make kratom a Schedule I drug, a substance that has "no now accepted medical use and a high potential for abuse". Kratom is already a controlled substance in 16 countries, including two of its native countries of origin, Thailand and Malaysia, as well as Australia, Sweden, and Germany.
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The herb is banned in several states, such as Indiana, Tennessee, Alabama, Arkansas and Wisconsin.
"FDA must use its authority to protect the public from addictive substances like kratom, both as part of our commitment to stemming the opioid epidemic and preventing another from taking hold". While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound-science and weighed appropriately against the potential for abuse. They must be put through a proper evaluative process that involves the DEA and the FDA.
Last year, the Drug Enforcement Administration proposed banning the use of kratom.
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