Is Kratom Harmless? Rising Adverse Event Signals

Author: Xiaotong Li, MS on August 07, 2023


In recent years, we have observed an upswing in the use of natural products (NPs) for complementary health. This surge in popularity is often linked to the perception of NPs as safe and natural alternatives. Kratom, one such product, has become widely available in the United States. The American Kratom Association estimates that between 10 and 16 million people regularly use Kratom as an opioid substitute or for recreational purposes. However, this increasing usage has precipitated safety concerns, as case reports involving Kratom have surged, and several case series have implicated it as a common factor in many fatalities.

In this context, a recent study published in Clinical and Translational Science by Xiaotong Li, Richard D. Boyce, Mary F. Paine and their colleagues offers crucial insights. The researchers analyzed adverse events (AEs) related to Kratom as reported to the US Food and Drug Administration Adverse Event Reporting System from October 2012 through September 2021. Their goal was to elucidate the patterns of Kratom-associated AEs. After deduplication, 489 unique Kratom-related cases were identified. These showed a rising trend of Kratom-related cases, with a remarkable 94.2% of Kratom-associated cases reported since 2018. The three most commonly reported AEs were death (20.9%), toxicity to various agents (16.0%), and drug dependence (10.8%). Additionally, interactions between drugs and Kratom were reported in ten cases. Alarmingly, nearly half of the Kratom-related cases resulted in death.

The study identified ten AEs with observed-to-expected (OE) ratios of no less than 10. This indicates these events had a ten-fold or higher probability of being reported in Kratom-related cases compared to the proportion in cases related to all other drugs and NPs (Figure). The events with the highest OE ratios were accidental death and positive drug screens.

This research highlights the urgent need for heightened awareness of Kratom-related AEs and potential interactions between Kratom and other drugs.

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