FDA Declares Kratom an Opioid

FDA Commissioner Scott Gottlieb released a statement deliniating the agency's concerns about the plant substance and its health consequences.

Scott Gottlieb, MD

The US Food and Drug Administration (FDA) has classified kratom, a botanical substance widely used as a painkiller despite agency approval, as an opioid.

FDA Commissioner Scott Gottlieb released a statement referencing the FDA’s concerns about the plant substance and its health consequences, which they said include death. Since they've been keeping tally, there have been 44 deaths reported that are considered associated with kratom, an increase from the 36 that had been reported in a November 2017 FDA advisory document.

Gottlieb noted that many of the reports the FDA has received regarding the substance weren't fully assessed due to a limited amount of available information. Still, he went on to raise concern with 1 specific report.

“This individual had no known historical or toxicologic evidence of opioid use, except for kratom,” Gottlieb said in his statement. “We’re continuing to investigate this report, but the information we have so far reinforces our concerns about the use of kratom.”

He noted that, additionally, some of the cases that were assessable with fatal outcomes drew agency concern about the use of kratom in combination with other drugs—specifically those with neurologic effects. These combination uses included illicit drugs, prescription opioids, benzodiazepines and over-the-counter medications

“Cases of mixing kratom, other opioids, and other types of medication are extremely troubling because the activity of kratom at opioid receptors indicates there may be similar risks of combining kratom with certain drugs, just as there are with FDA-approved opioids,” Gottlieb said.

The administration acknowledged that despite the information collected, there is still much to learn about the substance. Reportedly, there are current scientific assessments underway to further the understanding of the biologic effects of kratom.

“Notably, we recently conducted a novel scientific analysis using a computational model developed by agency scientists, which provided even stronger evidence of kratom compounds’ opioid properties,” Gottlieb said. “These kinds of models have become an advanced, common and reliable tool for understanding the behavior of drugs in the body. We also have learned more about deaths that involved kratom use and have identified additional adverse events related to this product. This new data adds to our body of substantial scientific evidence supporting our concerns about the safety and abuse potential of kratom.”

In previous statements, Gottlieb said that the agency must weigh all available evidence, and ask itself whether the use of kratom could expand the opioid epidemic. On the other hand, Gottlieb also acknowledged that if proponents are right, and kratom could be used alternatively as a tool to treat opioid addiction, the agency owes them clear, reliable evidence to support those benefits.

“I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence,” he wrote in a November 17 statement.

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