FDA cites 36 reported deaths linked to use of kratom-containing products, including kratom being laced with opioids such as hydrocodone.
Officials with the FDA have issued a public health advisory on kratom, warning consumers about the potential risks associated with its use.
In a statement, FDA Commissioner Scott Gottlieb, MD, noted that the product has been marketed and distributed as a treatment for conditions such as pain, anxiety, and depression—all serious conditions that require proper diagnosis and treatment from a licensed health care professional–despite being unapproved.
Kratom is naturally grown in Thailand, Malaysia, Indonesia, and Papua New Guinea, and is often imported into the United States to be sold as a treatment with a variety of healing properties. According to the FDA’s statement, kratom produces similar effects to narcotics such as opioids, and therefore carries similar risks of abuse, addiction, and in some cases, death.
Dr. Gottlieb cited 36 reported deaths linked to use of kratom-containing products, as well as reports of kratom being laced with other opioids like hydrocodone. Calls to US poison control centers regarding kratom have increased 10-fold from 2010 to 2015. Additionally, he noted that the substance is associated with serious adverse effects such as seizures, liver damage, and withdrawal.
“Given all these considerations, we must ask ourselves whether the use of kratom — for recreation, pain, or other reasons – could expand the opioid epidemic,” Dr. Gottlieb said in the statement. “Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits.”
The FDA has an issued guidance on the proper development of botanical drug products, as well as a team of medical reviewers in the FDA’s Center for Drug Evaluation and Research dedicated to the proper development of drug applications for botanicals. However, to date, no marketer has sought to properly develop a drug that includes kratom.
“While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound-science and weight appropriately against the potential for abuse,” Dr. Gottlieb said.
Currently, kratom is banned in Alabama, Arkansas, Indiana, Tennessee, and Wisconsin. Several other states have pending legislation to ban it. For kratom to be legally marketed for therapeutic uses, it would need to undergo the FDA’s regulatory drug review process to properly evaluate the risks and benefits.
For now, the FDA is continuing to take action against kratom-containing dietary supplements and actively prevent kratom products from being imported into the United States.
Statement from FDA Commissioner Scott Gottlieb, MD on FDA advisory about deadly risks associated with kratom [FDA statement]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584970.htm. Accessed November 14, 2017.