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FDA Warns Of Deaths Linked To Opioid-Like Kratom

14 November 2017

Kratom, a Southeast Asian plant known for its opiate-like effects, may put users at risk of addiction and even death, the US Food and Drug Administration said in a public health advisory today. Especially because the drug works on the same receptors, adherents believe it has therapeutic potential.

In some cases reported to the FDA, kratom is laced with opioids like hydrocodone (Vicodin), Gottlieb noted. The FDA is aware of 36 deaths linked to the use of products containing kratom.

The DEA almost made it a Schedule 1 drug in 2016, which would have put it in the same category as heroin, marijuana and LSD, but ultimately scrapped the plan.

These two uses are what Gottlieb appears to see as the most troubling.

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For now, the FDA treats kratom as an unapproved drug, and the agency has taken action against dietary substances that have it.

However, the FDA is not convinced that kratom belongs in unregulated hands.

FDA commissioner Scott Gottlieb also plans to tell his agency's criminal investigations staff that he may ask Congress for more authority and resources to fight the opioid epidemic, according to remarks prepared for delivery Tuesday afternoon. "We also know that this substance is being actively marketed and distributed for these purposes". In his statement, he wrote that calls to USA poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year. It has been linked with 36 deaths. Some products have risky substances other than kratom in them, including opioids.

"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.

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Kratom, a plant grown naturally in countries including Thailand and Malaysia, is widely sold in smoke shops and other locations as a powder that can be used in tea to slow the effects of opioid withdrawal. "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". Instead, Gottlieb mentioned that kratom is already a controlled substance in 16 countries, and that several states have pending legislation to ban it.

"I want to be clear on one fact: there are now no FDA-approved therapeutic uses of kratom", Gottlieb wrote.

In November, researchers at Harvard Medical School and independent product testing company NSF International identified four unapproved, unlisted stimulants in six supplements now marketed for weight loss and fitness.

Whether kratom will eventually be banned, however, depends on the Drug Enforcement Administration.

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FDA Warns Of Deaths Linked To Opioid-Like Kratom