Published: Wed, November 15, 2017
Medicine | By Melba Vasquez

FDA Warns About Dangers Of 'Natural' Opioid Kratom


The U.S. Food and Drug Administration on Tuesday raised concerns about kratom, saying there is no reliable evidence to support its use to treat opioid withdrawal symptoms, citing reports of 36 deaths associated with the use of kratom-containing products. Between 2010 and 2015, kratom-related calls to US poison control centers jumped 10-fold.

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. The plant's euphoric affect, which is similar to narcotics such as opioids, has led to recreational use as an alternative to opioids.

Previous year the Drug Enforcement Administration planned to make kratom a Schedule I drug, a category that includes marijuana and LSD, but decided against it after an outcry of opposition.

In some cases reported to the FDA, kratom is laced with opioids like hydrocodone (Vicodin), Gottlieb noted.

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The regulator said there are now no approved therapeutic uses of kratom, which is linked to serious side effects such as seizures and liver damage.

Data show that there is harm associated with the use of kratom.

"There are now no FDA-approved therapeutic uses of kratom", said Gottlieb.

Since then, there have been reports of 36 deaths linked with the use of products containing kratom; it can cause serious side effects including seizures and liver damage, and can even trigger symptoms of withdrawal when use is stopped, according to the FDA.

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At the request of the DEA, Gottlieb said, his agency has conducted a comprehensive scientific and medical evaluation of two compounds found in kratom and continues to actively prevent shipments from entering the country, and to destroy any that are seized. People who are taking the product to treat depression and opioid addiction may be putting themselves at risk, the agency says. The DEA said last October it would delay a decision until the FDA issued a recommendation.

So far, no marketer has tried "to properly develop a drug that includes kratom", Gottlieb said. The agency has already detained hundreds of packages at worldwide mail facilities.

"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". Instead, Gottlieb mentioned that kratom is already a controlled substance in 16 countries, and that several states have pending legislation to ban it. Currently, there appeared to be no companies reviewing kratom to be used for medicinal purposes.

"To those who believe in the proposed medicinal uses of kratom", he wrote, "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".

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