A few months ago, the Food and Drug Administration (FDA) warned people about the risks associated with the herbal substance kratom. The public health advisory was intended for people who use kratom as an alternative to opioids, due to its similar effects.
Now, FDA commissioner Scott Gottlieb has gone a step further by releasing what the agency says is strong evidence that kratom compounds are themselves opioids. Gottlieb said the FDA is concerned about the substance’s “potential for abuse, addiction, and serious health consequences; including death.”
“Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids,” Gottlieb said.
The commissioner said there had been 44 deaths associated with kratom, including one person who did not seem to have used any other opioids. Other people who died after taking kratom tended to have mixed it with other drugs of various kinds.
“We recognize the need and desire for alternative treatments for both the treatment of opioid addiction, as well as the treatment of chronic pain. The FDA stands ready to evaluate evidence that could demonstrate a medicinal purpose for kratom. However, to date, we have received no such submissions and are not aware of any evidence that would meet the agency’s standard for approval,” Gottlieb said.
“For individuals seeking treatment for opioid addiction who are being told that kratom can be an effective treatment, I urge you to seek help from a health care provider.”