ATLANTA and WASHINGTON, Nov. 29, 2017 /PRNewswire-USNewswire/ -- A new review bythe American Kratom Association (AKA) of the FDA Adverse Event Reporting System (FAERS) database maintained by the U.S. Food and Drug Administration (FDA) shows that, from 2011-2017, not a single death has been attributed solely to kratom anywhere in
Dave Herman, chair of the board, American Kratom Association said: "Our message today is very simple. Kratom is a safe botanical that does not kill people. If the Government bans kratom, more people will die. Kratom is an alternative to opioids, not a gateway to opioid abuse. The American Kratom Association supports appropriate FDA regulations to ensure product quality and safety for consumers."
Addiction expert Dr. Jack Henningfield, vice president of Research, Health Policy, and Abuse Liability at PinneyAssociates, said: "Recently there have been reports of kratom-associated deaths in the media. It is important to understand, and the FDA's own data confirms this, that there has not been a single verified report of an acute poisoning death that we can say with certainty was caused by kratom use. Most of the kratom-associated deaths occurred in people who had various pre-existing illnesses and/or were taking multiple substances with known serious health risks that may have been significant contributors to or causes of the reported deaths. The contribution of kratom, if any, to these deaths, is not known."
Dr. Henningfield added: "We need every asset to dig our way out of the deep hole that is the opioid crisis. We need to find a path for kratom to continue to realize its benefits to help keep kratom available as a path away from opioids, and to not replace the legal marketplace with the black market that will surely emerge in the vacuum of a lawful market. It makes no sense to take kratom out of the equation and risk avoidable opioid epidemic deaths."
The American Kratom Association reviewed the 2011-2017 data in the FDA's Adverse Event Reporting System (FAERS) and found no deaths attributed solely to kratom.
Mac Haddow, legislative director, American Kratom Association, said: "The 'signal' for public action on kratom is incredibly insignificant in the broader context of deaths reported and adverse events reported under the FAERS system. The point is that this should not even be consuming the resources of the FDA given its status in the overall reporting of adverse events and deaths. It clearly illustrates a political agenda, rather than a scientific agenda, at the FDA. Out of just 42 times that kratom is mentioned in FAERS since 2011, there is not a single death associated with kratom itself, and every one of them is related to the co-administration of other toxic levels of a prescription drug or illegal substance. The point is that the FDA did not even use its own reporting system to validate the Health Advisory on kratom. They looked to outside publicly available literature that is far vaguer and open to interpretation because their own data does not support their thesis."
Haddow cited examples of other products, including Heparin and Loperamide, that became the subject of death-related concerns and were subjected to tighter quality controls and testing, rather than a ban. Dr. Henningfield and Haddow noted that fairness alone would dictated that kratom, with a market of three million consumers, should receive the same kind of treatment.
At a news conference in Atlanta, AKA also unveiled a "statement of principle" on kratom: "The American Kratom Association recognizes that every effort should be made to keep kratom risks low, and protect consumers from adulterated and contaminated kratom products. With appropriate FDA consumer regulation, we can maximize the potential for kratom to be responsibly used for the improvement of the health and well-being of individuals and public health in America. To that end, AKA supports the following efforts:
Dr. Henningfield previously served as chief of the Clinical Pharmacology Research Branch of the National Institutes of Health's National Institute on Drug Abuse (NIDA), and is currently an adjunct professor of Behavioral Biology in the Department of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine. Dr. Henningfield and his PinneyAssociates colleagues conducted a comprehensive review of publicly available data on the same eight factors that the DEA and FDA weigh on in deciding to control a substance.
According to that analysis, kratom is not an opiate, it has not been linked to any known deaths, and the plant has little potential for abuse and dependence – as low or lower than such widely used (and federally unscheduled substances) as "nutmeg, hops, St. John's Wort, chamomile, guarana, and kola nut."
View original content:http://www.prnewswire.com/news-releases/national-expert-no-cases-show-deaths-solely-from-coffee-like-herb-kratom-which-should-be-handled-no-differently-than-other-substances-300563629.html
SOURCE American Kratom Association, Washington, D.C.
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