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Pharmaceuticals / Regulatory Affairs

FDA Warns Against Use of Kratom as Opioid Substitute

Nov. 17, 2017

The FDA issued a public health advisory against the use of the plant-based supplement kratom as an unapproved alternative to opioids.

FDA Commissioner Scott Gottlieb warned of mounting concerns over its use to treat conditions such as anxiety, depression or pain, and its marketing for similar purposes. The agency is particularly concerned with the use of kratom to treat opioid withdrawal.

Between 2010 and 2015, kratom-related calls to poison control centers increased 10-fold, and the FDA is aware of 36 deaths associated with the drug, as well as reports of kratom laced with other opioids such as hydrocodone.

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