MARLYAND, United States – February 2018: Recently, the Food and Drug Administration (FDA) has released an analysis based on a computational model to evaluate the adverse health events associated with kratom (Mitragyna speciosa). The FDA developed the Public Health Assessment via Structural Evaluation (PHASE) methodology – a tool that uses the molecular structure of a substance to predict its biological function in the body. In addition, the FDA has also released a report of adverse events associated with kratom use, from case report information. In the United States, 44 death cases have been associated with the use of kratom.

At the global level, 36 countries have reported the emergence of kratom to the UNODC Early Warning Advisory on NPS.

For more information, please see:

FDA Statement
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm595622.htm

Reported adverse events in case report information
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM595575.pdf