FDA on Tuesday issued a public health advisory on the risks associated with using kratom—a plant substance that some experts say could be used as an alternative to opioid painkillers.
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, but FDA and the Drug Enforcement Administration (DEA) in recent years have taken steps to curb Kratom's use.
FDA advisory details
FDA Commissioner Scott Gottlieb in a statement said, "There are currently no FDA-approved therapeutic uses of kratom." Further, he said, "There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder."
According to Gottlieb, calls to U.S. poison control centers in regard to products containing kratom increased tenfold from 2010 to 2015. Gottlieb said FDA is aware of 36 deaths associated with the use of products containing kratom and "has evidence to show that there are significant safety issues associated with its use," including liver damage, seizures, and withdrawal symptoms.
Gottlieb said, "Given all these considerations, we must ask ourselves whether the use of kratom—for recreation, pain, or other reasons—could expand the opioid [misuse] epidemic." He added, "Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits."
Gottlieb said FDA has a process for evaluating the safety and effectiveness of botanical drug products, but "[t]o date, no marketer has sought to properly develop a drug that includes kratom." He added that "using the FDA's … drug review process would provide for a much-needed discussion among all stakeholders."
Jack Henningfield, a substance use disorder specialist at Pinney Associates and an adjunct professor at Johns Hopkins, said kratom's "overall abuse potential and risk of death isn't anything close to narcotics like opioids." He warned that imposing a ban or restrictions on kratom could cause some individuals to relapse in their recovery from an opioid use disorder.
Walter Prozialeck, chair of the pharmacology department at Midwestern University Chicago College of Osteopathic Medicine, said kratom as an active "drug" does have the potential to have harmful effects and lead to misuse, but "overwhelming evidence indicates kratom is far less dangerous than classic opioids." Prozialeck said, "The therapeutic potential of kratom is real, but more research is urgently needed to evaluate its safety and efficacy" (McGinley, "To Your Health," Washington Post, 11/14; Stein, "Shots," NPR, 11/14; O'Donnell, USA Today, 11/14; Grover/Clarke, Reuters, 11/14; FDA release, 11/14).
Reduce opioid misuse and abuse with our new report
Opioid misuse and abuse is one of the most pressing public health issues in the U.S., and hospitals and health systems are on the front lines. Currently, most health systems focus their opioid management efforts on select medical specialties.
This report outlines three imperatives to guide hospitals and health systems in their efforts to reduce the impact of inappropriate opioid prescribing and misuse.