Home / Health / What is kratom? The popular herbal supplement has caught flak from the FDA

What is kratom? The popular herbal supplement has caught flak from the FDA

Bobby DiBernardo credits the herbal supplement kratom with getting him off heroin, oxycodone and alcohol six years ago.

"It saved my life," he said. “I could have died every day from an overdose of heroin and kratom gave me a new lease. It helped to remove the pain from withdrawal. "

DiBernardo, 41, of Rochester, New York, still mixes a teaspoon of herbal powder into a glass of water once or twice a day and drinks it even though he says it tastes awful.

He is just one of the millions of Americans – potentially up to 1

5 million, according to estimates from the American Kratom Association (AKA) – to use kratom, a supplement made from the leaves of the Mitragyna speciosa tree native to Southeast Asia. Since at least the 19th century, the leaves have either been chewed or brewed in tea by people in Thailand, Malaysia and Indonesia to relieve pain, ease fatigue and increase mood. Kratom is believed to act as a stimulant in lower doses and has opioid-like analgesic effects and soothing properties at higher doses.

But as the supplement has increased in popularity in the United States, security concerns have prompted food and drug administration to warn consumers against kratom use and to turn down companies that engage in fraudulent health claims.

"We have issued many warnings about the serious risks associated with the use of kratom, including warnings about contamination of kratom products with high prices of salmonella which exposed people using kratom products in the risk zone and resulted in many diseases and reminders, ”says FDA Commissioner Dr. Ned Sharpless in a statement in June 2019, when the agency issued warning letters to two companies selling kratom. "Despite our warnings, companies continue to sell this dangerous product and make misleading medical claims that are not backed by science or any reliable scientific evidence."

Six states – Alabama, Arkansas, Indiana, Rhode Island, Vermont and Wisconsin – and the District of Columbia have even taken the step of prohibiting the addition.

It's a move that kratom advocates, including Lois Gilpin, 58, of Louisville, Kentucky, opposes.

Gilpin has mixed kratom powder in her orange juice about two or three times a day for four years and says it relieves the chronic pain in her left leg and back so that she can now get out of bed and enjoy her family again. "It's definitely not a fix-all," Gilpin said. "But to make it work well enough for me to get my grandchildren out of school and take them to the park is huge."

She was so impressed with kratom that she began volunteering to coordinate social media AKA's, a consumer association group in Virginia founded in 2014.

So is kratom really all it has been about? Or need more caution?

How is kratom used in the United States?

An online survey in 2016 with more than 8,000 kratom users contacted primarily through AKA found that most people used the product to relieve pain or to treat mood disorders such as depression and anxiety. Others used kratom to combat withdrawal symptoms from prescription opioid or illicit drug use.

Most often, kratom is consumed as a powder mixed in a drink or in pill form, according to the study, conducted by Oliver Grundmann, a clinical associate professor of medical chemistry at the University of Florida and published in the journal Drug and Alcohol Dependence.

Is there solid evidence that kratom is favorable?

"So far we do not have real clinical studies, rigorous studies that we do for drugs that the FDA requires before a drug is approved to enter the market," Grundmann said.

The strict "gold standard" is not required before supplements can Instead, "what we have primarily are the favorable uses reported in a traditional environment in East Asia, and surveys and user reports in the US and Europe," he said.

In his study, the most reported benefits of kratom have decreased pain, increased energy, and better mood. The majority of reported benefits benefit at doses up to five grams taken up to three times a day.

Kratom often comes in powder form. Mary Esch / AP file

" I would say we have relatively good anecdotal emerging evidence that kratom has benefits for the average user as long as we consider how much kratom turns and what products are used, says Grundmann.

But although there may be encouraging anecdotal reports of benefits, some experts say. requires more research.

Is kratom safe?

It depends on who you ask – and opinions vary greatly.

The FDA has issued a strong warning against kratom use. "The FDA is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, addiction and addiction," the group says.

"There are no FDA-approved uses for kratom, and the agency has received concerning reports on the safety of kratom," the FDA said in a statement. "The FDA is actively evaluating all available scientific information on this issue and continues to warn consumers not to use any products labeled containing the botanical substance kratom or its psychoactive compounds, mitragynin and 7-hydroxymitragynin."

In fact, in 2016, the Drug Enforcement Administration went so far as to temporarily list kratom as a controlled substance in Schedule 1 – a classification that means it has no accepted medical use and high potential for abuse – only withdraw the decision after a public outcry and a targeted presentation by advocates.

The FDA has also expressed concern that kratom products may be contaminated with heavy metals or salmonella, and that marketers make misleading health claims.

For example, the 2018 supplement was linked to a multistate outbreak of salmonella, which requires mandatory recall by the FDA. (A specific source of that contamination was not identified, but it may have occurred during the cultivation or manufacturing process.) And an April 2019 analysis of 30 different kratom products found traces of heavy metals, including lead.

During the summer, the FDA issued two warning letters to sell "unapproved, incorrectly labeled kratom-containing drug products with unproven claims about their ability to treat or cure opioid dependence and withdrawal symptoms."

It's the illusion that it's a plant so it's going to be OK.

Dr. Paul Earley, an addictive medicine specialist in Atlanta and president of the American Society of Addiction Medicine, said he treats patients who are addicted to kratom, including a new patient who was recovering from opioid addiction when switching to kratom and thought it was safe . That patient must later be admitted to hospital for kratom dependence.

"It's the illusion that it's a plant, so it's going to be OK, it's milder than heroin – and yes, it's true – but it's not a safe compound," Earley told NBC News.

"Kratom produces a physical addiction, and people who are particularly susceptible to abuse should stay away from it, as it will tickle the same part of the brain that opioids do," he added. [19659002] Two reports this year linked kratom use to various negative effects, even death.

A study in the journal Clinical Toxicology found that between 2011 and 2017, over 1,800 conversations with kratom were placed at US poison control centers. The most common complaints were agitation / irritability and rapid heartbeat followed by nausea, drowsiness, vomiting, confusion and high blood pressure. But there were also some reports of serious complications such as seizures, respiratory problems, coma and, in 11 cases, deaths. Nine of the deaths involved other drugs such as cocaine, fentanyl and alcohol, but two cases were only attributed to kratom.

Another report, from the Centers for Disease Control and Prevention, looked at more than 27,000 drug doses that were part of a multistate database between July 2016 and December 2017 and found that 91 Americans died of kratom overdoses. Most cases included multidrug use, including fentanyl, heroin and benzodiazepines. But in seven cases, kratom was the only compound revealed in the test after mortem. However, the researchers noted that "the presence of additional substances cannot be ruled out."

Critics say that these types of reports are difficult to draw firm conclusions about the cause and effect that other contributing factors may play. [19659002] AKA claims that there have been no deaths directly as a result of kratom products which are undamaged and have not been used in combination with other drugs. "Kratom has been used safely for centuries in Southeast Asia where there are no deaths associated with pure kratom consumption," said Mac Haddow, AKA's senior general policy officer. "In the United States, there are no deaths related to pure kratom consumption."

What is the future of kratom?

While some healthcare professionals support a kratom ban, others say regulation would be a better way.

Dr. Peter Grinspoon, a primary care physician and instructor at Harvard Medical School, said banning kratom would leave many chronic pain sufferers without an alternative they can rely on if they want to avoid prescription opioids or can't get them from their doctor.

Grinspoon recommends that his patients avoid kratom because of the lack of regulation.

"If you buy kratom you don't know what you're getting," he said. "Do you really get one gram of kratom or do you get one gram of what is in the capsules in the powder that they call kratom? There is no monitoring of growth, production, packaging, distribution or sale of kratom."

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