"These reports underscore the serious and sometimes deadly risks of using kratom and the potential interactions associated with this drug", he said, including one death in which the person had no known history of opioid use.
"As the scientific data and adverse event reports have clearly revealed, compounds in kratom make it so it isn't just a plant - it's an opioid", FDA commissioner Scott Gottlieb said in a statement.
A scientific analysis found stronger evidence that compounds in kratom have opioid properties, according to FDA Commissioner Scott Gottlieb, MD, who added that the agency has now received 44 reports of deaths linked to the Asian plant.
The substance, which is imported from Southeast Asia and marketed as a supplement, has become increasingly popular among consumers looking for relief from pain, anxiety and depression as well as opioid-withdrawal symptoms. In 2016, the DEA proposed a ban on kratom but backtracked under pressure from some members of Congress and outcry from kratom advocates who said it could help treat opioid addiction. But other researchers warn that the herb, taken in capsules or by drinking tea, is too risky to use.
"Today, the agency issued a public health advisory related to the FDA's mounting concerns regarding risks associated with the use of kratom".
In the FDA statement, Gottlieb said that "cases of mixing kratom, other opioids, and other types of medication is extremely troubling".
Mixing kratom with over-the-counter drugs can intensify these effects, the FDA warned.
In 2016, the Drug Enforcement Administration (DEA) announced plans to temporarily list kratom as a Schedule I controlled substance, which would put it in the same category as heroin.
Dr. Gottlieb concluded that there is no evidence to support kratom's safety or efficacy in any medical use.
The FDA provided that evaluation late past year.
The new data contributes to the agency's concern about kratom's potential for abuse. The simulation suggested that 22 of the 25 compounds in the substance would bind to the body's opioid receptors, which is said to indicate that kratom could affect humans in the same way as opioids.
Based on the new FDA new research, along with information from previous studies and reports of harmful effects tied to kratom, "we feel confident in calling compounds found in kratom, opioids", Gottlieb said in a statement.
Although a number of deaths have been linked to use of kratom, it's unclear if the deaths are a direct result of using the drug, Marc Swogger, an associate professor of psychiatry at the University of Rochester Medical Center in NY, told Live Science in a 2016 interview. The plant has since garnered a large following in the United States, with three to five million users, according to the American Kratom Association.
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