FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Declares Kratom an Opioid

Feb. 12, 2018
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The FDA declared the herbal product kratom to be an opioid, citing “compelling evidence” from computational models and 44 reported deaths — up from the 36 deaths the agency reported last November.

The 25 most prevalent compounds in kratom are structurally similar to controlled opioid analgesics, and two of the five most prevalent are known to activate opioid receptors.

One of the 44 fatalities was a person with no history of using any other opioid, noted FDA Commissioner Scott Gottlieb. Other deaths suggest kratom is being used along with prescription opioids, benzodiazeprines and over-the-counter drugs such as loperamide, the anti-diarrheal drug for which the FDA proposed packaging limitations last week in response to increased abuse to manage opioid withdrawal symptoms.

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