Medicine

FDA warns of 'deadly risks' of the herb kratom, citing 36 deaths

FDA warns of 'deadly risks' of the herb kratom, citing 36 deaths

"Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product's dangers, potential side effects or interactions with other drugs", he wrote.

The Food and Drug Administration says there's insufficient evidence the supplement works to treat addiction or other problems and cited growing evidence it can be unsafe.

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.

The United States is in the grip of an opioid epidemic. President Donald Trump recently declared the crisis a public health emergency. Additionally, the FDA is aware of reports of 26 deaths associated with the use of kratom-containing products, and that there have been reports of kratom being laced with other opioids like hydrocodone.

Meanwhile, a similarly troubling trend has been seen with kratom. Around the same time in 2012, the FDA "first put kratom on import alert" FDA press officer Lyndsay Meyer told Business Insider. Kratom may cause seizures, liver damage and withdrawal symptoms.

Between 2010 and 2015, calls about kratom to poison control centers rose 10-fold from just 26 to 263, according to the Centers for Disease Control and Prevention.

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The commissioner stressed the need to evaluate the drug's potential benefits and harms. If the plant is useful in treating various conditions, it should go through the agency's regular drug-approval process to provide it is safe and effective, he added.

So far, no marketer has tried "to properly develop a drug that includes kratom", Gottlieb said. 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.

Kratom is banned in Australia, Malaysia, Myanmar, and Thailand and in several U.S. states - Alabama, Arkansas, Indiana, Tennessee, and Wisconsin.

"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", Gottlieb wrote.

The FDA said it is working to prevent shipments of kratom in the United States and has detained hundreds of these packages at worldwide mail facilities.


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