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In the United States, nearly 100 kratom-related deaths were revealed last week by the Centers for Disease Control and Prevention (CDC), highlighting potential concerns about the safety of the botanical product.
But the CDC report does not establish that kratom actually caused death, said C.M. Haddow, senior policy researcher with American Association of Kratom (AKA), a non-profit organization whose mission is to promote access to botany.
Kratom, otherwise known as Mitragyna speciosa, is a tree native to Southeast Asia that is taken in pill form and consumed in various forms by millions of Americans, including those seeking to wean opioids.
During a review of more than 27,000 overdose deaths in 27 states between July 2016 and December 2017, the CDC identified 152 people who had tested positive for kratom. The coroner or medical examiner determined that kratom "was a cause of death (involved in kratom)" in 91 cases, the health protection agency reported, although the CDC noted that almost all people tested were positive for other substances, such as fentanyl.
Haddow said that coroners and forensic scientists do not know the level at which pure kratom is toxic.
"Documentation of post-mortem toxicology testing protocols is needed to clarify how kratom contributes to fatal overdoses," concluded CDC.
The report suggests determining the exact causes of deaths is complicated because almost all of the deceased patients were positive for other substances, including heroin, fentanyl – the potent synthetic opioid – and cocaine.
In seven deaths, individuals were only positive for kratom, but the CDC could not exclude the presence of other substances.
In about 80% of deaths involving kratom, "the deceased had a history of substance abuse and about 90% had no evidence that they were currently receiving supervised pain treatment." medical, "revealed CDC.
Similarly, a recent analysis of 15 kratom-attributed deaths in Colorado revealed that almost all of them involved the presence of multiple substances, including fentanyl analogues, suggesting that kratom alone Was probably not the cause of the deaths.
The results, published in the New England Journal of Medicine, suggest that kratom could contribute to "some dangerous conditions when it is associated with other drugs," such as respiratory depression, said Daniel Vigil, MD, of the Department of Public Health and Health. Colorado Environment (CDPHE), in an interview with Diary of nutrition (NBJ). (Editor's note: Informa plc has both NBJ and Natural Products INSIDER).
However, it is unclear what role kratom played in the deaths, and Vigil stated that it is possible that kratom does not contribute at all to deaths. The Colorado health official agreed that more research was needed to investigate the potential side effects of kratom.
FDA previously disclosed in 2018 The use of kratom has been associated with 44 deaths. But the deaths involved products intentionally adulterated with other dangerous substances and other factors, said Haddow. For example, one person died in a homicide following a gunshot wound in the chest, wrote Jane Babin, Ph.D. white paper The AKA published in August 2018.
By reporting the 44 deaths associated with kratom over a nine-year period, the FDA has not "diligently verified or diligently conducted any due diligence in death reports, and even worse, its own records indicate that each reported case involves 'other factors,' proclaimed Babin.
On his websiteThe National Institute on Drug Abuse (NIDA) noted that many deaths reported by the FDA appeared to be due to adulterated products or taking botanicals with others. powerful substances such as alcohol, illegal drugs and opioids. The government institute also cited reports of kratom in the form of dietary supplements or dietary ingredients, but enriched with other compounds that could lead to death.
Haddow said that "bad actors" use kratom to improve its effects.
"What you have, it's a dietary ingredient and a herbal supplement very much used by these bad actors," he said in a phone interview. "That's the reason you see these deaths related to kratom."
The FDA has repeatedly expressed concern that kratom poses health risks to consumers and may deter opioid addicts from seeking conventional medical treatment and obtaining medications that have been shown to be effective and safe.
FDA early 2018 determined kratom compounds share structural similarities with controlled opioids such as morphine derivatives. Using a computer model developed by FDA scientists, the agency discovered two of the most common compounds in kratom, including mitragynine, which researchers have described as the primary active component of kratom-activating receptors. opioids.
A few months later, the agency announced the sending of warning letters sellers of kratom who claim to "relieve opium withdrawals" and treat a variety of other ailments, including alcoholism, depression and diabetes.
Scott Gottlieb, MD, then commissioner of the FDA, said his agency was not alone in worrying about what he termed "opioids found in kratom" . A number of states and municipalities in the United States have banned the substance, and kratom is illegal or controlled in several other countries, including Australia, Denmark, Germany, Malaysia and Thailand, he noted.
Adding to the concerns of the FDA: Recent laboratory tests of 30 different kratom products from various sources in which the agency identified "significant concentrations of lead and nickel at concentrations exceeding safe exposure for daily oral drug use".
"Based on these test results," the FDA concluded, "long-term kratom users could potentially develop heavy metal poisoning, including nerve and kidney damage, anemia, hypertension, and or an increased risk of certain cancers "
The DEA is studying the possibility of regulating kratom as a controlled substance in response to an FDA recommendation. In one letter to the DEA partially obtained by the media company STAT, HHS has recommended that mitragynine and 7-OH-mitragynine be permanently monitored in Schedule I of the Controlled Substances Act (CSA).
"Individuals take the substance in sufficient quantities to harm their health, the safety of others or the community," the letter said.
Botanical advocates maintain a US ban on kratom could exacerbate the opioid crisis by depriving consumers of a safe alternative to addictive and dangerous drugs.
In September 2018, AKA asked the Department of Health and Human Services (HHS) – of which the FDA is a member – to recall its schedule recommendation to the DEA. The FDA has no "scientific basis" for its claim that kratom is "dangerously addictive," said AKA President Dave Herman in a statement. letter at HHS. Regarding the question of whether kratom is dangerous, he referred to NIDA's statements.
"Congress never provided that the Controlled Substances Act (…) be used to prohibit substances deliberately adulterated with other poisonous or lethal drugs causing death, and nothing in the law or the law." Legislative history does allow this abuse of power in the programming recommendation introduced by the FDA, "wrote Herman.
Barbara Carenno, a spokeswoman for the DEA, said in an email in November 2018 that there was no deadline for the planning process and that it could take years. If the DEA finally decides to program the kratom, the agency will issue a notice and the public will have the opportunity to submit comments during which the kratom will remain unplanned, she said.
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