FDA on Tuesday released a new warning about the risks associated with using the supplement kratom, citing research that suggests the substance has "opioid properties" and has been associated with 44 deaths in the United States.
Kratom is a substance that is derived from a tree native to Southeast Asia. In the United States, the substance has become a popular alternative treatment for individuals with chronic pain, as well as those trying to stop using alcohol or opioid drugs. Kratom's active ingredients include a chemical that binds to some of the same receptors in the body as opioids, which in turn can provide pain relief and a type of high.
Kratom is available in the United States as a dietary supplement, and the American Kratom Association estimates that between 3 million and 5 million U.S. residents have used or are using kratom. FDA and the Drug Enforcement Administration (DEA) in recent years have taken steps to curb kratom's use, and FDA in November 2017 issued a public health advisory about the supplement.
FDA issues new warning
FDA Commissioner Scott Gottlieb in a statement released Tuesday said, "Over the past several months, there have been many questions raised about the botanical substance known as kratom," adding that "there is still much that is unknown about" the supplement. To address that issue, Gottlieb said FDA "recently conducted a novel scientific analysis using a computational model developed by agency scientists, which provided even stronger evidence of kratom compounds' opioid properties."
In addition, Gottlieb said FDA has "learned more about deaths that involved kratom use, and [has] identified additional adverse events related to this product." According to Gottlieb, the number of reported deaths associated with kratom in the United States rose from 36 between April 2011 and November 2017 to 44 between April 2011 and December 2017, including one death in which the "individual had no known historical or toxicologic evidence of opioid use, except for kratom."
Gottlieb said the agency also has received evidence that individuals are using kratom in conjunction "with other drugs that affect the brain, including illicit drugs, prescription opioids, benzodiazepines, and over-the-counter medications, like the anti-diarrheal medicine, loperamide." Overall, Gottlieb said, "This new data adds to [FDA's] body of substantial scientific evidence supporting [the agency's] concerns about the safety and abuse potential of kratom."
Gottlieb also stressed that "kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids." He said FDA has grown particularly "concerned about the use of kratom to treat opioid withdrawal symptoms, as there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist."
Warning comes as DEA considers whether to classify kratom as a controlled substance
FDA's latest warning comes as DEA is weighing whether to classify kratom as a controlled substance, the Washington Post's "To Your Health" reports.
DEA in 2016 withdrew a proposal to place kratom on its controlled substance list, which would have effectively prohibited the substance's use in the United States. According to "To Your Health," DEA back peddled on the proposal in response to pressure from advocates who said the substance could be used to help treat opioid use disorders, as well as some lawmakers. DEA at the time asked FDA to accelerate its medical and scientific evaluation of kratom.
According to "To Your Health," a DEA spokesperson on Tuesday said it could take "months or even years" for the agency to decide whether to classify kratom as a controlled substance (McGinley, "To Your Health," Washington Post, 2/6; FDA statement, 2/6; Perrone, AP/Sacramento Bee, 2/6).
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