FDA: Kratom an Opioid, Associated With 44 Deaths

The scientists also attacked the bad science the FDA used to claim deaths from kratom use, pointing out that "the fatalities that the FDA lists as having been associated with kratom include deaths with a wide variety of apparent causes in people suffering from various diseases and/or taking other substances that also likely contributed to their deaths".

The Food and Drug Administration declared this week that Kratom, a substance many opioid addicts have credited with helping them kick addictions, is a unsafe drug.

"We feel confident in calling compounds found in kratom, opioids", Food and Drug Administration commissioner Scott Gottlieb said in a statement.

US health authorities say an herbal supplement promoted as an alternative pain remedy contains the same chemicals found in opioids, the addictive family of drugs at the center of a national addiction crisis.

"Importantly, as commonly used in raw plant form, it does not appear to produce the highly addictive euphoria or lethal respiratory depressing effects of classical opioids", the group, including scientists from Johns Hopkins University, Columbia University and the University of Rochester, wrote. Advocates call it a safe way to deal with chronic pain and other conditions, and some researchers are exploring whether it helps people overcome addictions. While many of these cases could not be fully assessed because of limited information, one new report of death, in which the individual had no known historical or toxicologic evidence of opioid use besides kratom, was of particular concern.

As of February 6, 2018, FDA has reported 44 deaths involving the use of kratom; an increase from 36 reported in November 2017.

The FDA has submitted its review to the Drug Enforcement Administration, which is considering whether to place kratom in the same category of illegal drugs as heroin and LSD.

FDA officials have recommended kratom be categorized as a Schedule 1 drug, which would effectively mean that scientists would not be able to study its effects. FDA has stepped in, concerned over the product's lack of scientific evidence to support medical claims.

Gottlieb said his agency developed its computational model to identify the possibility of abuse of designer street drugs for which there is little pharmacological data.

Using that model, FDA scientists analysed the 25 most common compounds in kratom and concluded that all of them share the most structural similarities with opioid painkillers such as morphine derivatives. Further analysis confirmed that two of the most prevalent compounds in kratom are known to activate opioid receptors, and that kratom has a strong bind to mu opioid receptors, comparable to those of scheduled opioid drugs.

The American Kratom Association noted that a ban on kratom could result in up to $5 billion in financial losses by 10,000 kratom-related vendors.

Warning Over Kratom: What's the Real Impact for Pain Practitioners?

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