FDA Warns Against Using Kratom Products for Opioid Treatment

Commissioner Scott Gottlieb issued a statement warning about the risks associated with kratom.
Nov 14, 2017
By Pharmaceutical Technology Editors

On Nov. 14, 2017, FDA Commissioner Scott Gottlieb, MD, issued a statement regarding the risk of using kratom. Marketers have been selling kratom, a plant grown in parts of Asia, as a treatment for a variety of conditions including pain, anxiety, and depression. The plant’s euphoric affect, which is similar to narcotics such as opioids, has led to recreational use as an alternative to opioids. FDA warns that the plant has the same risks of abuse, addiction, and possibly, death.

Some patients with opioid addiction are using kratom to treat their addiction. The agency states, however, that there is no reliable evidence that kratom can be used to treat opioid use disorder. “Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed healthcare provider about the product’s dangers, potential side effects, or interactions with other drugs,” Gottlieb said in the statement.

Data show that there is harm associated with the use of kratom. There have been 36 deaths reported in associated with the plant’s use, according to the agency, and calls to poison control centers in the United States increased 10-fold from 2010–2015. Serious side effects associated with kratom include seizures, liver damage, and withdrawal symptoms.

FDA has taken action against dietary supplements containing kratom and is working to prevent shipments from entering the country. Hundreds of shipments have been detained and product has been seized and destroyed. “In response to a request from the Drug Enforcement Administration (DEA), the FDA has conducted a comprehensive scientific and medical evaluation of two compounds found in kratom. Kratom is already a controlled substance in 16 countries, including two of its native countries of origin, Thailand and Malaysia, as well as Australia, Sweden, and Germany. Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee, and Wisconsin and several others have pending legislation to ban it,” Gottlieb stated.

“FDA must use its authority to protect the public from addictive substances like kratom, both as part of our commitment to stemming the opioid epidemic and preventing another from taking hold ... While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound-science and weighed appropriately against the potential for abuse. They must be put through a proper evaluative process that involves the DEA and the FDA. To those who believe in the proposed medicinal uses of kratom, I encourage you to conduct the research that will help us better understand kratom’s risk and benefit profile, so that well studied and potentially beneficial products can be considered. In the meantime, based on the weight of the evidence, the FDA will continue to take action on these products in order to protect public health,” Gottlieb said in the statement.

Source: FDA

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