The U.S. Food and Drug Administration (FDA) says one person died, and many others experienced severe adverse effects after consuming OPMS Black Liquid Kratom supplement.
Kratom is a plant found in Southeast Asia known for its pain-relieving and stimulant effects. It contains compounds similar to opioids and has not been approved by the FDA to treat any health condition. Moreover, the Drug Enforcement Administration (DEA) lists kratom as a "Drug and Chemical of Concern."
Despite its unapproved status, supplements containing kratom are marketed unlawfully and sold online and in some retail stores. According to Substance Abuse and Mental Health Services Administration (SAMHSA) estimates, 1.7 million people in the United States used kratom in 2021. Consumers may believe kratom supplements are safe since they're derived from a "natural" plant.
However, in a July 26 consumer alert, the FDA warned consumers not to purchase or use Optimized Plant Mediated Solutions (OPMS) Black Liquid Kratom after the Agency received reports that one person died and several others experienced serious health effects after consuming the herbal supplement.
Serious adverse health effects associated with the product include liver toxicity, seizures, and substance use disorder (SUD).
Other health issues linked to OPMS Black Liquid Kratom include addiction, digestive issues, withdrawal symptoms, restless leg syndrome, skin problems, increased anxiety, aggressive behavior, lack of energy, and inability to focus.
The FDA says OPMS Black Liquid Kratom labeling shows the supplement contains kratom alkaloids, mitragynine, and 7-hydroxymitragynine (7-OH mitragynine).
This is not the first time health officials have warned consumers about the potential dangers of kratom use, as the compound has been previously linked to severe adverse effects and dozens of deaths.
Are kratom-related deaths underestimated?
According to a 2023 study, the American Kratom Association reports that 10 to 16 million people use kratom regularly, a number that far exceeds SAMHSA estimates.
To learn more about the potential impact of kratom, the scientists who conducted the study analyzed the FDA Adverse Event Reporting System (FAERS) data to compare kratom-related adverse effects to other natural products. They found that the observed number of kratom‐related accidental deaths was 63.1‐fold greater than expected.
In addition, the compound was strongly linked to addiction and drug withdrawal.
"Although further research is needed to assess the safety of kratom, clinicians and consumers should be aware that real‐world evidence points to potential safety threats," the study's authors wrote.
However, in a 2023 press release, Mac Haddow, American Kratom Association (AKA) Senior Fellow on Public Policy, said, "The safety and addiction profile of pure, unadulterated kratom is well-documented by science and there is no known level of kratom use that would cause any fatality unless it is irresponsibly consumed, adulterated with a toxic drug, or used in concurrently with a deadly drug substance."
Haddow says consumers are "caught in the trap between the FDA" who fail to act on its duty to regulate kratom responsibly.
The AKA supports actions to develop and implement FDA standards for the manufacturing and marketing of kratom products to protect consumers.
Meanwhile, the FDA, U.S. Department of Justice, U.S. Customs and Border Protection, and other federal agencies continue to combat the illegal sale of this unapproved compound in the U.S. by refusing kratom shipments and seizing kratom products.
5 resources
- FDA. FDA and kratom.
- DEA. Kratom.
- FDA. FDA warns consumers not to use Optimized Plant Mediated Solutions (OPMS) Black Liquid Kratom.
- Clinical and Translational Science. An evaluation of adverse drug reactions and outcomes attributed to kratom in the U.S. Food and Drug Administration Adverse Event Reporting System from January 2004 through September 2021.
- American Kratom Association. Consumer advisory on FDA's failure.
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