US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD has issued a public health advisory warning against the use of kratom, a plant that grows naturally in southeast Asia that has gained popularity in the US as an unapproved treatment for pain, anxiety and depression.
The FDA's cautioning comes after the Drug Enforcement Administration's delay in listing kratom, a plant found in countries like Thailand and Malaysia, as a controlled substance. "Before it can be legally marketed for therapeutic uses in the US, kratom's risks and benefits must be evaluated as part of the regulatory process for drugs that Congress has entrusted the FDA with". "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".
"Importantly, evidence shows that kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in some cases, death".
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The FDA said it is aware of 36 deaths involving products made with kratom and hundreds of calls to poison control centers. Because it produces symptoms, such as euphoria, similar to opiates, it is also used recreationally. Anita Gupta, an osteopathic anesthesiologist and licensed pharmacist, has expressed concern about an increase in the use of kratom among her chronic pain patients. 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. He stated, "There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder". After a public outcry, the DEA chose to postpone its decision, and asked the FDA to weigh in. Some products have risky substances other than kratom in them, including opioids. The agency has also identified kratom products on 2 import alerts, and is actively working to prevent shipments of kratom from entering the US. The agency has already detained hundreds of packages at global mail facilities. The supplement is sold in smoke shops and as a powder for brewing tea to ease drug withdrawal symptoms but, according to the FDA, it has addictive characteristics of its own. The DEA will review the FDA's assessment and make a determination, says DEA spokesperson Wade Sparks.
"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.