In a statement on the advisory, FDA Commissioner Scott Gottlieb, MD, pointed to the “clear data on the increasing harms associated with kratom.”
Citing both its obligation to protect the public’s health and its mounting safety concerns over the botanical kratom, FDA issued a public health advisory on November 14 related to the potential risks of using kratom.
A tropical tree native to Southeast Asia and parts of Oceana, kratom (Mitragyna speciosa) bears leaves containing psychoactive opioid compounds. The leaves have been used in traditional medicine and for their purported mood-altering and pain-relieving effects for years. Those properties, as well as the notion that kratom might help treat opioid withdrawal symptoms, have increased its popularity and led some marketers to promote the botanical as a safe, plant-based product with a wide range of health benefits.
Yet in a statement on the advisory, FDA Commissioner Scott Gottlieb, MD, pointed to the “clear data on the increasing harms associated with kratom.” In addition to a tenfold increase in kratom-related calls to US poison control centers from 2010 to 2015, Gottlieb said, “FDA is aware of reports of 36 deaths associated with the use of kratom-containing products.” Use of such products is linked to side effects ranging from seizures and liver damage to withdrawal symptoms.
Thus, Gottlieb continued, FDA finds it “very troubling” that patients might use kratom to treat opioid withdrawal symptoms, given that there “is no reliable evidence to support the use of kratom as a treatment for opioid use disorder.” Moreover, he said, “We must ask ourselves whether the use of kratom-for recreation, pain or other reasons-could expand the opioid epidemic.”
While there are as yet no FDA-approved therapeutic uses for kratom, Gottlieb leaves the door open for their future consideration-so long as the botanical’s risks and benefits are evaluated pursuant to FDA’s drug-review process. “While we remain open to the potential medicinal uses of kratom,” Gottlieb said, “those uses must be backed by sound-science and weighed appropriately against the potential for abuse.”
To date, no marketer has undertaken the proper development of a kratom-containing drug, but, speaking directly to potential developers, Gottlieb said, “I encourage you to conduct the research that will help us better understand kratom’s risk and benefit profile, so that well studied and potentially beneficial products can be considered.” In the meantime, the agency will continue taking action against kratom products that threaten public health. Kratom is already a controlled substance in 16 countries and is banned in Alabama, Arkansas, Indiana, Tennessee and Wisconsin, with legislation to ban it pending it in several other states.