A person died after using kratom product, FDA says. Agency warns not to use it

A kratom product that’s sold in some stores and available to buy online should be avoided, the Food and Drug Administration is warning after one user’s death.

The FDA recently learned a person died after consuming OPMS Black Liquid Kratom — one of several “serious” reports linked to the product advertised as a “kratom extract,” according to a July 26 FDA alert.

Kratom, or mitragyna speciosa, is a tree that grows naturally in Southeast Asia, where it’s been used for centuries, and can be consumed in a variety of ways. In the U.S., products containing kratom are marketed as having therapeutic benefits, but they aren’t legal.

Anyone who has purchased OPMS Black Liquid Kratom should not use it, the FDA says.

In addition to one reported death, OPMS Black Liquid Kratom is also “linked to serious adverse health effects,” including withdrawal symptoms, addiction, digestive problems, aggression, heightened anxiety and restless leg syndrome, according to the FDA.

The product is central to a Georgia family’s lawsuit over the death of 23-year-old Ethan Pope in December 2021, McClatchy News previously reported.

Pope died after consuming OPMS Black Liquid Kratom, according to the lawsuit, which says his friends found him dead in his home.

Attorney Matt Wetherington, who’s representing Pope’s family, told McClatchy News on Aug. 2 that the case is ongoing.

“The FDA’s consumer alert on OPMS Black Liquid Kratom is a rare and serious action that demands our full attention,” Wetherington said in a statement.

OPMS Kratom is promoted by the American Kratom Association, which denounced the FDA’s recent warning about OPMS Black Liquid Kratom in a July 29 news release.

The organization is calling on the agency to remove the alert, accusing the FDA of not independently verifying the claims about the person’s death.

“Kratom products should be proven safe before widespread use, not the other way around,” Wetherington said.

People use kratom for a variety of purposes, including to self-treat pain, anxiety, depression, opioid use and opioid withdrawal, the FDA says. About 1.7 million Americans ages 12 and older were estimated to be kratom users in 2021.

In smaller doses, kratom can produce stimulant effects, according to the Centers for Disease Control and Prevention. If taken in higher doses, it can produce effects similar to opioids.

The FDA says there is not enough information available that can ensure kratom products in the U.S. are safe and haven’t been adulterated.

The agency said it will continue “to monitor emerging data trends to better understand the substance and its components.”

In July 2023, a federal judge in Florida ordered a kratom distributor to pay more than $11 million in damages to the family of Krystal Talavera, who died after using kratom, according to a lawsuit, McClatchy News reported.

Talavera, a mother of four who worked as a nurse in West Palm Beach, had consumed a kratom product labeled “Space Dust,” the lawsuit says.

Following an autopsy, her official cause of death was listed as “acute mitragynine intoxication” by the Palm Beach County coroner, according to the lawsuit.

In December, a Tampa Bay Times investigation found more than 580 Florida residents have died from consuming kratom in the past 10 years.

Wethernigton said kratom needs “strict oversight.”

To report an adverse reaction to a product, the FDA advises calling a consumer complaint coordinator or filling out a Voluntary MedWatch form.

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