Deadly kratom could add to opioid epidemic, FDA official says

The government — whether its federal, state or local — can’t seem to make up its mind about kratom, a substance sold at head shops, gas stations and kava bars that a Palm Beach County mother blames for her son’s death. Advocates say it can be a tool in fighting the opioid epidemic and is a safe pain reliever.

Now the Food and Drug Administration has entered the mix, issuing a public health advisory this past week, stating that kratom has raised “significant concerns, given its increasing prevalence and potential safety risks” and discounting its use in helping struggling addicts. The agency called it a deadly risk.

“We have a critical point in the opioid epidemic,” FDA Commissioner Scott Gottlieb said in a statement. “The increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning.”

He acknowledged people are using kratom to treat pain, anxiety and depression but expressed worry that these people were treating those serious conditions without consulting a physician.

The FDA noted that calls to U.S. poison control centers regarding kratom increased 10-fold from 2010 to 2015 and that the agency is aware of 36 deaths associated with products containing the drug.

“Given all these considerations, we must ask ourselves whether the use of kratom — for recreation, pain or other reason — could expand the opioid epidemic,” Gottlieb said

The FDA’s public warning might open the door for the Drug Enforcement Administration to make kratom illegal. The DEA has said it was waiting for the FDA to make its move, according to The New York Post.

The DEA back-pedaled this past year on making the Southeast Asian leafy plant illegal after congressional lawmakers urged the agency to give the public a chance to comment. The DEA planned to name kratom a Schedule I drug, which would put it on a list with other illegal drugs such as heroin that have no accepted medical use and high potential for abuse.

This do-si-do followed a proposed state law on kratom being pulled from consideration in the Florida Legislature in April 2015 after its sponsor, Rep. Kristin Jacobs, D-Coconut Creek, said more research was warranted. The Palm Beach County Commission about the same time decided to hold off on plans requiring warning signs at shops that sold the herbal drug.

Kratom users claim the drug improves focus and induces euphoria in certain amounts. While the DEA didn’t make it illegal, it was listed as a drug of concern as it is marketed legally as an alternative to controlled substances. It is often brewed in a tea and served in a coconut shell but can be taken in other forms, such as by a capsule or a powder mixed into a smoothie-like drink.

One of the fiercest opponents of kratom is Linda Mautner of Delray Beach. She blames her son Ian’s suicide in July 2014 on addiction to kratom and has previously said she has been discouraged by the government’s on-again, off-again efforts to reign in the drug. Packets of kratom were found in Ian’s car after he jumped to his death from a highway overpass into traffic on Interstate 95.

She has said that people think kratom is safe because it is marketed as “all-natural.” She said some kratom dealers have been cyberbullying her on social media.

“This what they do to parents of children who have died,” Mautner said. “I saw what kratom did to him (her son). It was a drug for him.”

Without government regulation, Mautner said kratom users have no idea what they are getting. “You don’t know if you are purchasing kratom, if it’s a true product or if it’s been adulterated,” she said.

If kratom is a drug that can be used for opiate addicts or for pain, then it needs to go through the same testing and procedures as any other medication, she added.

The National Institutes of Health at the universities of Mississippi and Massachusetts found that a kratom extract was useful in treating opioid withdrawal and possibly other addictive drugs.

Justin Kunzleman, director of Rebel Recovery, who has been an advocate of alternative treatment for opioid abuse, said kratom is safer than Tylenol based on deaths attributed to each and the risk of overdose. “It’s shown great results for detox and harm reduction in opiate users,” he said.

He was skeptical that the FDA is really interested in science-based facts considering it once approved the marketing of OxyContin as non-addictive. OxyContin, a legal and often abused opioid prescription painkiller, is considered by those in the drug abuse recovery industry as the on-ramp to the current crisis gripping the country.

The FDA “allowed drugs to go to market knowing they have a far greater risk than any proven to be associated with kratom,” Kunzleman said.

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