FDA Issues a Public Health Advisory Regarding the Dangerous Plant Kratom

In 2014 and 2016, the Food and Drug Administration (FDA) worked with federal marshals to seize large amounts of raw kratom and kratom-containing dietary supplements.[1],[2]

On Nov. 14, 2017 and Feb. 6, 2018, the agency took a firmer stand by issuing two public health advisories warning against using this substance,[3],[4] which has been falsely touted by some marketers as a safe treatment that has broad healing properties.

The advisories — which were issued by FDA commissioner Scott Gottlieb — outline the agency’s mounting concerns about the risks associated with kratom and warn consumers not to use products that contain this substance.

About kratom

Kratom is a tropical tree native to Southeast Asia, where this plant was used historically as a stimulant by laborers and farmers who chewed on its leaves to help provide relief from muscle strains due to hard work.[5] Kratom also has been used as a recreational drug, as a substitute for opium and to manage opioid-withdrawal symptoms among chronic opioid users.

The planting of kratom has been banned in Thailand since 1943. Kratom currently is classified as a controlled substance in 16 countries — including two of its native countries, Thailand and Malaysia, in addition to some western countries, including Australia, Sweden and Germany.[6] It also has been banned in several states — such as Alabama, Arkansas, Indiana, Tennessee and Wisconsin — and several other states are considering legislation to ban it.

The National Institute on Drug Abuse classifies kratom as a psychoactive (mind-altering) substance and as an opioid.[7] The FDA has not approved kratom for any therapeutic uses.[8] Recently, the agency has taken measures to stop the importation of kratom to the U.S. and has seized and overseen the destruction of some kratom-containing products.

The Drug Enforcement Administration has considered kratom a “drug of concern” because it is an unregulated substance but still poses risks to those who abuse it.[9] In 2016, the agency attempted to temporarily classify kratom and any drugs derived from it as schedule I controlled substances — a classification for substances with no valid medical uses but a high potential for abuse[10] — which could have criminalized its sale and use. However, the agency quickly rescinded its decision under considerable pushback from kratom supporters,[11] spearheaded by the American Kratom Association.

Thus, kratom remains available in the U.S. online and in stores,[12] as a powder and in capsule, tablet and liquid forms.

FDA concerns

In his November 2017 statement, the FDA commissioner noted the lack of reliable evidence to support the use of kratom[13] for any of its purported uses, such as treating pain, anxiety, depression and opioid use disorder. No marketer has sought marketing approval from the FDA to develop a drug that includes kratom.

Therefore, kratom users take these unapproved products without dependable instructions for use and, more importantly, likely without consultation with licensed health care professionals who are aware of the dangers, potential adverse events and interactions of this substance with other drugs.

There have been numerous reports of serious reactions associated with use of kratom. The FDA has identified 44 reported deaths related to kratom[14] and has released adverse event reports from its MedWatch program for some of those death cases.[15] A recent report by the Centers for Disease Control and Prevention found a tenfold increase in calls to poison control centers about kratom exposure from 2010 to 2015.[16] The study found that 7 percent of the reported cases were classified as major and life-threatening; 42 percent required medical treatment but were not classified as life-threatening. About one-third of these calls involved the use of other substances of abuse, including benzodiazepines and narcotics, in addition to kratom.

Serious adverse events associated with use of kratom include seizures, liver damage and slow or shallow breathing.[17] Cases of psychosis — hallucinations, delusion and confusion — also have been reported in association with use of kratom.[18]

Importantly, kratom has been linked to abuse, addiction[19] and withdrawal symptoms, including emotional changes, insomnia, irritability, muscle aches and runny nose.[20] For this reason, the FDA fears that kratom could expand the opioid epidemic.

In fact, in February the FDA commissioner expressed confidence in calling compounds found in kratom opioids, based on computer-model analyses performed by the agency’s scientists, which found 22 of 25 compounds in kratom that they analyzed would bind strongly to opioid receptors.[21] Another risk associated with kratom is its being laced with other opioids, such as hydrocodone (HYSINGLA, NORCO, ZOHYDRO ER), due to the lack of appropriate quality-control measures during the packaging and sale of this unregulated substance.

What You Can Do

Due to its addictive nature and other adverse events, in addition to the absence of scientific evidence supporting its effectiveness, you should not use kratom for any reason. If you or your loved ones suffer from severe pain, depression, anxiety or addiction, seek professional medical care and never self-medicate with unapproved products. See the February 2018 issue of Worst Pills, Best Pills News for details on approved prescription drugs to treat opioid addiction.[22] Report all serious adverse events related to kratom to the FDA’s MedWatch adverse event reporting program by visiting http://www.fda.gov/MedWatch or by calling 800-FDA-1088.

References

[1] Voelker R. Kratom products seized. JAMA. 2016;316(11):1142.

[2] Food and Drug Administration. FDA and kratom. Updated February 6, 2018. https://www.fda.gov/newsevents/publichealthfocus/ucm584952.htm. Accessed February 7, 2018.

[3] Statement from FDA commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom. November 14, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584970.htm< /a>. Accessed February 9, 2018.

[4] Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse. February 6, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm595622.htm< /a>. Accessed February 7, 2018.

[5] Drug Enforcement Administration. Kratom (mitragyna speciosa korth) – (Street names: thang, kakuam, thom, ketum, biak). January 2013. https://www.deadiversion.usdoj.gov/drug_chem_info/kratom.pdf. Accessed February 9, 2018.

[6] Statement from FDA commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom. November 14, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584970.htm< /a>. Accessed February 9, 2018.

[7] National Institute on Drug Abuse. Drug facts: kratom. February 2016.https://www.drugabuse.gov/publications/drugfacts/kratom. Accessed February 9, 2018.

[8] Statement from FDA commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom. November 14, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584970.htm< /a>. Accessed February 9, 2018.

[9] Drug Enforcement Administration. Drugs of abuse. 2017. https://www.dea.gov/pr/multimedia- library/publications/drug_of_abuse.pdf#page=84. Accessed February 9, 2018.

[10] Drug Enforcement Administration. Notice of Intent. Schedules of controlled substances: Temporary placement of mitragynine and 7-hydroxymitragynine into schedule I. August 25, 2016. https://s3.amazonaws.com/public-inspection.federalregister.gov/2016- 20803.pdf. Accessed February 9, 2018.

[11] Drug Enforcement Administration. Withdrawal of notice of intent to temporarily place mitragynine and 7-hydroxymitragynine Into schedule I. October 13, 2016. https://www.federalregister.gov/documents/2016/10/13/2016- 24659/withdrawal-of-notice-of-intent-to-temporarily-place-mitragynine-and-7- hydroxymitragynine-into. February 9, 2018.

[12] Tavakoli HR, Buchholz AC, Kabir IK, et al. Kratom: An emerging drug of abuse. Emerg Med. 2017;May:209-214.

[13] Statement from FDA commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom. November 14, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584970.htm< /a>. Accessed February 9, 2018.

[14] Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse. February 6, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncemaents/ucm595622.htm . Accessed February 7, 2018.

[15] Food and Drug Administration. Kratom death adverse event reports through December 15, 2017. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformati on/cderfoiaelectronicreadingroom/ucm595575.pdf. Accessed February 7, 2018.

[16] Anwar M, Law R, Schier J. Notes from the field: kratom (mitragyna speciosa) exposures reported to poison centers — United States, 2010-2015. Morb Mortal Wkly Rep. 2016;65(29):748-749.

[17] Statement from FDA commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom. November 14, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584970.htm< /a>. Accessed February 9, 2018.

[18] Drug Enforcement Administration. Kratom (mitragyna speciosa korth) – (Street names: thang, kakuam, thom, ketum, biak). January 2013. https://www.deadiversion.usdoj.gov/drug_chem_info/kratom.pdf. Accessed February 9, 2018.

[19] Yusoff NHM, Suhaimi FW, Vadivelu RK, et al. Abuse potential and adverse cognitive effects of mitragynine (kratom). Addict Biol. 2016;21(1):98-110.

[20] National Institute on Drug Abuse. Drug facts: kratom. February 2016. https://www.drugabuse.gov/publications/drugfacts/kratom. Accessed February 9, 2018.

[21] Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse. February 6, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncemaents/ucm595622.htm . Accessed February 7, 2018.

[22] Buprenorphine for opioid addiction. February, 2017. Worst Pills, Best Pills News. https://www.worstpills.org/newsletters/view/1086. Accessed February 7, 2018.