August 16, 2018

FDA Releases Information About Opioid Compounds in Kratom

The FDA released information about adverse events and scientific analysis providing evidence of opioid properties in kratom, an ingredient used in some dietary supplements. Food Poisoning Bulletin told you about a warning the FDA issued last November about this ingredient, stating that the substance is addictive and has been linked to deaths in this country.

Warning About Kratom

The FDA conducted a scientific analysis using a computational model developed by scientists in the agency, which provides “even stronger evidence of kratom compounds’ opioid properties.” More adverse events involving this product have been reported. Government officials are concerned about the use of this substance to treat opioid withdrawal symptoms. The press release states that “there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist.”

The tool the FDA used helped them simulate how chemical constituents of a substance are structured at a molecular level, how they behave in the body, and how they can affect the brain. Scientists analyzed the chemical structures of the 25 most prevalent compounds in kratom, and concluded that all of those compounds share structural similarities with controlled opioid analgesics.

The scientist then analyzed the chemical structure of those compounds to discover its biologic target. The model predicted that 22 of the 25 compounds studied bind to mu-opioid receptors, which confirms that two of the top five most prevalent compounds in kratom active opioid receptors.

The model also predicted that some of those compounds bind to receptors in the brain that contribute to stress responses. Those responses affect neurologic and cardiovascular function. Seizures and respiratory depression are two of the serious side effect associated with kratom.┬áBecause of this research, the FDA states that “we feel confident in calling compounds called in kratom, opioids.”

The FDA has placed kratom products on import alert to stop importers from bringing the product into the country illegally. The government has received 44 reports of death associated with the use of this compound. That is an increase of 8 deaths since the advisory issued in November 2017.

While there are FDA-approved opioids that have undergone reviews for safety and efficacy, kratom has not been investigated by that agency. The FDA states that this compound should not be used to treat medical conditions or used as an alternative to prescription opioids. The press release states, “There is no evidence to indicate that kratom is safe or effective for any medical use.”

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