FDA Warns of Herbal Supplement Kratom's Opioid-Like Harms

From Drugs.com - November 14, 2017

FDA Warns of Herbal Supplement Kratom's Opioid-Like Harms

TUESDAY, Nov. 14, 2017 -- The U.S. Food and Drug Administration on Tuesday issued an advisory about harms tied to kratom -- an imported herbal supplement with opioid-like effects that is increasing in popularity.

People are taking the unapproved supplement to treat conditions like pain, anxiety and depression -- without medical supervision, FDA Commissioner Dr. Scott Gottlieb said in a statement. Others use kratom for its euphoric effects, or to wean addicts off opioids such as prescription painkillers or heroin, also without medical say-so.

"Importantly, evidence shows that kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and, in some cases, death," Gottlieb said. "At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning."

The United States is in the grip of an opioid epidemic. Since 2000, more than 500,000 Americans have died from a narcotic overdose, according to the U.S. Centers for Disease Control and Prevention. President Donald Trump recently declared the crisis a public health emergency.

Meanwhile, a similarly troubling trend has been seen with kratom. Between 2010 and 2015, kratom-related calls to U.S. poison control centers jumped 10-fold. And 36 deaths have been linked to kratom-containing products. Kratom use can also cause seizures, liver damage and withdrawal symptoms, the FDA said.

In the United States, there are no FDA-approved uses for kratom, which grows naturally in Southeast Asia.

In some cases reported to the FDA, kratom is laced with opioids like hydrocodone (Vicodin), Gottlieb noted.

The commissioner stressed the need to evaluate the drug's potential benefits and harms. He said kratom products must go through the FDA's drug review process before they can be legally marketed for therapeutic uses in the United States.

"This is especially relevant given the public's perception that it can be a safe alternative to prescription opioids," he added.


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