FDA Identifies New Unregulated Opioid

The US Food and Drug Administration (FDA) now warns that the unregulated botanical substance kratom contains opioid compounds, emphasizing its potential for abuse, addiction, and other serious health consequences.

In particular, the FDA has raised concerns regarding the use of kratom to treat symptoms of opioid withdrawal. The FDA says that, to date, it is not aware of any submissions for the formal evaluation of kratom, nor of any evidence of a medicinal purpose for kratom that would meet the FDA’s standard for approval.

The FDA issues its statement following the completion of a novel scientific analysis using a computational model developed by agency scientists. Ultimately, through the analysis, they found strong evidence of opioid properties in kratom compounds, indicating potential dangers associated with use of the substance.

The serious side effects associated with kratom include seizures and respiratory depression.

—Christina Vogt

Reference:

Statement from FDA commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse [press release]. US Food and Drug Administration. February 6, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm595622.htm. Accessed on February 7, 2018.