Thursday, 23 November, 2017

FDA chief warns about kratom to treat opioid addiction

FDA warns against using kratom for opioid addiction FDA Issues Warning Against Kratom, A Naturally Occurring but Unapproved Plant
Marlene Weaver | 15 November, 2017, 02:11

Leaves from the kratom tree, which grows in Southeast Asia and is distantly related to coffee plants, have been touted as a potential treatment for opioid withdrawal, among other conditions. "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". "Before it can be legally marketed for therapeutic uses in the USA, kratom's risks and benefits must be evaluated as part of the regulatory process for drugs that Congress has entrusted the FDA with".

As a result, the agency has begun seizing supplies of kratom and taking steps to prevent future shipments from being imported into the United States, the FDA says.

Kratom has a particular compound, called mitragynine, which binds to the same receptors that opioids like heroin does, Chemical & Engineering News reported.

"There are now no FDA-approved therapeutic uses of kratom", said Gottlieb. "The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms".

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Aside from being marketed online and in largely unregulated supplements as a concentration booster and workout enhancer, kratom is being advertised as a replacement for opioid painkillers.

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. "Calls to USA 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 Drug Enforcement Administration temporarily listed kratom as a Schedule 1 controlled substance last August, but withdrew the decision after an outcry and a targeted petition effort. "In the meantime, based on the weight of the evidence, the FDA will continue to take action on these products in order to protect public health", Gottlieb said in the statement. But for now, no company has tried to properly develop a drug that includes kratom. "To those who believe in the proposed medicinal uses of kratom, I encourage you to conduct the research that will help us better understand kratom's risk and benefit profile, so that well studied and potentially beneficial products can be considered". Hundreds of shipments have been detained and product has been seized and destroyed.

Nevertheless, the drug has continued to pop up in supplements, prompting the FDA to issue a health alert in 2014 about kratom-containing dietary supplements and bulk dietary ingredients.

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