During the current opiate addiction epidemic, kratom, a plant from Southeast Asia, has grown in popularity as a safer alternative to opioids to treat conditions such as pain, anxiety and depression. But the U.S. Food and Drug Administration (FDA) recently warned that those who use the plant-based substance may face the risk of addiction or even death.
The potential safety risks for kratom raise “significant concerns,” according to the FDA. The FDA said it knows of 36 deaths caused by the the use of products containing kratom. Calls to poison control centers regarding kratom increased 10 times from 2010 to 2015, FDA data indicates.
Kratom, which grows in Thailand, Malaysia, Indonesia and Papua New Guinea, binds to the same opioid receptor as morphine. As a result, some scientists think it might have the ingredients to develop less addictive pain medications. But it’s being used widely as a recreational drug, and to treat opioid withdrawal.
The FDA is calling for more medical research to test its benefits and safety. “At a time when we have hit a critical point in the opioid epidemic,” the FDA statement said, “the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning.”
Last year, the U.S. Drug Enforcement Administration announced plans to deem kratom a Schedule I drug, the most restrictive classification, which incluldes heroin and LSD. Based on negative public feedback, the DEA decided to postpone its decision, and asked the FDA to provide input.
Some scientific groups are concerned that the DEA’s plans to reclassify kratom as a Schedule 1 substance will hamper medical research on the substance. “The Schedule I status has historically made it more difficult for researchers to gain access to the compounds,” says Brad Burge, the director of communications and marketing at the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS).
“The DEA’s rule to schedule it to make it less available is just completely opposed to the best interest of research and completely opposed to the best interest of public health,” Burge told TheVerge.com.
Many government organizations, like the National Institutes of Health, and other funding agencies are more cautious about funding studies on Schedule I drugs, says Burge. And that’s the primary way that DEA’s scheduling undermines scientific research. “Clearly the stigma associated with a Schedule I drug can make it more difficult for funding,” Burge says.
A number of studies have shown kratom to have positive medicinal benefits, according to the American Kratom Association. A 2015 study in Dove Press Journal concluded kratom merits further study to develop its medical benefits, as a better opioid substitute, with fewer lethal side effects.
A 2014 study in the Pacific Journal of Cancer Prevention concluded the plant could yield anti-oxidant and anti-cancer compounds. The AKA says at least four patents have been filed on the primary constituents of the plant.
The group also contends that adverse reactions from kratom have not been widespread.
The National Forensic Laboratory Information System, the DEA database that collects information from forensic labs throughout the country shows kratom appears in just a fraction of one percent of all reports for substances in 2013 (173 times) and 2014 (137 times) – a much smaller incidence of problematic side effects than some over the counter pain relievers.
Kratom is only habit-forming when taken in high doses for extended periods of time, the AKA says. When discontinuing use, users may experience dependence (similar to caffeine dependence) and discomfort.
It’s still easy to obtain kratom online and in some stores. But some who dsitrubte kratom may be mixing it with other substances, including opioids such as hydrocodone, the FDA says.
And, kratom has been connected to serious side effects such as liver damage, seizures and withdrawal symptoms. People who use it to treat depression and opioid addiction may be taking a serious health risk, the agency says.
“Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product’s dangers, potential side effects or interactions with other drugs,” FDA Commissioner Scott Gottlieb wrote in the advisory.
If companies want to market kratom for its alleged health benefits, they need to go through the FDA’s drug review process, Gottlieb said, so that any new product can be tested for safety and effectiveness. But no company has yet sought regulatory approval for a drug containing kratom.
“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,” Gottlieb wrote. Meanwhile, the FDA is continuing its efforts to keep kratom from being shipped to the U.S.