THURSDAY, Aug. 3, 2023 (HealthDay News) -- J.D. Butler was planning a future with his girlfriend at his favorite New York City restaurant when that future came to a sudden, crushing halt.

“They were planning on when she was moving in and arranging floor plans on the table, with where the furniture was going to go,” said his mother, Karen Butler, a lifelong New York resident. “And he had a grand mal seizure, and then his heart stopped.”

A subsequent autopsy revealed that J.D.'s fatal seizure was brought on by mitragynine toxicity, caused by long-term ingestion of the widely used herbal supplement kratom, Butler said.

“She said there was evidence in his organ tissue that it had been in his body consistently for a while,” Butler said. “It’s one of those drugs to which you develop a tolerance, so you have to keep taking more and more and more.”

Kratom is coming under fire in the United States, targeted by a series of lawsuits following wrongful deaths associated with its use.

A Florida jury awarded $11 million last week to the family of a woman who died after taking kratom, in a lawsuit against the company that sold her the supplement, according to NBC News.

The woman, a 39-year-old mother of four, collapsed in her kitchen while making breakfast for her family in June 2021. A coroner said Krystal Talavera died from “acute mitragynine intoxication.”

“Never in a million years did she think that the kratom would kill her,” Tamara Williams, a lawyer representing Talavera’s estate, told NBC News.

And earlier in July, a Washington jury awarded $2.5 million in what is considered the first successful kratom wrongful death case.

In that lawsuit, jurors held a kratom seller liable for the death of Patrick Coyne, a 39-year-old marine mechanic and father of three in Castle Rock, Wash.

Coyne died in his sleep in June 2020. A coroner’s report attributed his death to “toxic effects of mitragynine [kratom],” according to a press release from his attorneys.

The American Kratom Association responded to these judgments by issuing a “consumer advisory on the [U.S. Food and Drug Administration’s] failure to properly regulate kratom products.”

“The FDA’s irresponsible war on kratom and the Agency’s refusal to implement product manufacturing and marketing standards has led to the marketing of dangerous kratom products exposing consumers to unacceptable risks,” Mac Haddow, the association's senior fellow on public policy, said in an association news release.

“Recent reports of product liability awards for irresponsibly manufactured or marketed kratom products are the direct result of the FDA’s complete failure to regulate the kratom marketplace and, in some cases, the exploitive behavior of trial attorneys who do nothing to compel the FDA to act responsibly,” Haddow added.

Similar to opioids

Kratom is an herbal supplement derived from the dried leaves of a tropical evergreen tree in the coffee family.

The mitragynine in kratom tweaks some of the same brain receptors that respond to opioids. Kratom has been used for centuries in its native Southeast Asia to produce increased energy and relaxation, according to the U.S. National Institute on Drug Abuse.

People these days use it to treat chronic pain, depression and anxiety, NIDA says. Some even use it to blunt the symptoms of opioid withdrawal.

About 1.7 million people 12 and older used kratom in the United States in 2021, according to the National Survey on Drug Use.

“While kratom has been used for centuries in traditional practices, it is not without risks,” said Pat Aussem, vice president of consumer clinical content development at the Partnership to End Addiction.

“Some potential side effects of kratom include nausea, constipation, dizziness, dry mouth and loss of appetite,” Aussem continued. “Long-term use of high doses may lead to dependence and withdrawal symptoms when not used.”

The FDA has not approved kratom, but as an herbal supplement it exists in a gray area of the law. The FDA is not allowed to regulate kratom as it would a prescription drug.

Still, the agency has warned Americans not to use kratom for medical treatment, as it does all unapproved substances. An FDA fact sheet notes that kratom binds to the same brain receptors as codeine, and may also act on other chemical systems in the brain.

Anyone can buy kratom online, and it can be found at convenience stores, gas stations and vape shops. Some bars serving botanical drinks offer kratom tea.

J.D. Butler -- a healthy, athletic 27-year-old elementary school teacher -- had been taking kratom for two to three years before his seizure and cardiac arrest, Karen Butler said.

His girlfriend “said he used to call it his ‘tea.’ He was taking it because he, like me and millions of others, had generalized anxiety disorder, and it helped him with that," his mother said.

Butler was at the family’s weekend house in Connecticut in 2019 when she got a frantic call from J.D.’s girlfriend, as paramedics were loading him into an ambulance outside the restaurant.

“While I’m on the phone with her, I heard the paramedics go, he’s coding! He’s coding! And that was the last I heard,” Butler remembers.

“It took us two hours to drive back, but by the time we got there, he was gone,” she said.

The coroner’s report came out about six to eight weeks after J.D.’s death. When it did, the coroner called Butler to explain the report.

“She said mitragynine toxicity is the cause of death, and mitragynine is the primary drug in kratom,” Butler said. “He didn’t have so much in his system that it was a singular overdose. It was more using it for long periods of time.”

One of the worst moments came when Butler shared online what she’d learned about kratom’s apparent role in her son’s death.

“What's incredible was the backlash we got from people who use it, people we didn't even know,” she recalls. “Wow, they were not happy with me.”

“It was horrible,” Butler continued. “They were demanding we send them the autopsy results. They were telling me, “Oh, it's a shame you didn't know your son. He was a heroin addict, because that's the only thing that explains what happened.’ I mean, it was just horrible.”

The Butlers ultimately decided to not pursue a lawsuit because J.D. purchased his kratom from several different sources, based on the packages they found at his apartment after his death.

“We weren’t sure which did it," Butler said.

Regulation is needed

The U.S. Department of Health and Human Services considered making mitragynine a scheduled drug in 2018, “but reversed course for several reasons,” Aussem said.

“Not only was there a great deal of pushback from the public and members of Congress, but there was concern that people using kratom might switch to opioids, further exacerbating the opioid crisis,” Aussem noted.

In a 2018 letter, HHS Senior Advisor for Opioid Policy Dr. Brett Giroir said the decision was based “in part on new data and in part on the relative lack of evidence.”

Giroir called for more research into how kratom is used, its addictive properties and whether it has any merit as a medical treatment.

Aussem noted that several states have banned kratom or added it to the list of controlled substances. These include Alabama, Arkansas, Indiana, Rhode Island, Vermont and Wisconsin.

The Partnership to End Addiction has not taken a formal position on kratom, Aussem noted.

“That said, in the context of kratom as a ‘treatment’ for opioid withdrawal, the Partnership only supports the use of medications and other treatments that are evidence-based and approved by the FDA,” Aussem said. “Broadly speaking, we would be concerned about the risks unregulated addictive substances pose to youth.”

There’s also a risk that kratom could be laced with other substances, such as synthetic opioids, Aussem said.

In its advisory, the American Kratom Association warned consumers to not consume kratom products that:

• Have not been certified by an independent third-party lab to be free of dangerous contaminants or contains adulterants that could be dangerous to consume.
• Are offered for sale from a vendor that markets its product with illegal therapeutic claims.
• Do not contain the name of the product distributor so that a consumer can file an adverse event report if required.
• Are delivered in unprofessional packaging, i.e., zip-close bags, product information written with a pen or sharpie, or handwritten product information.

The association says it has submitted more than 75 documented complaints of kratom manufacturers making illegal therapeutic claims for the supplement, “and the FDA has not prosecuted a single case in three years.”

However, Haddow maintained that “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 concurrently with a deadly drug substance.

“The consumer is caught in the trap between the FDA who refuses to act on its duty to responsibly regulate kratom, and some trial attorneys who benefit financially from the lack of FDA regulation on kratom,” Haddow concluded.

More information

The U.S. National Institute on Drug Abuse has more about kratom.

SOURCES: Karen Butler, New York City; Pat Aussem, LPC, MAC, vice president, consumer clinical content development, Partnership to End Addiction; NBC News; American Kratom Association, news release, July 31, 2023