Pubdate: Tue, 14 Nov 2017
Source: Philadelphia Daily News (PA)
Copyright: 2017 Philadelphia Newspapers Inc.
Contact: http://www.philly.com/dailynews/about/feedback/
Website: http://www.philly.com/dailynews/
Details: http://www.mapinc.org/media/339

FDA WARNS OF HERB KRATOM'S OPIOID-LIKE HARMS

(HealthDay News) -- 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.

So far, no marketer has tried "to properly develop a drug that
includes kratom," Gottlieb said.

"While we remain open to the potential medicinal uses of kratom, those
uses must be backed by sound science and weighed appropriately against
the potential for abuse," Gottlieb added.

In 16 countries, kratom is a controlled substance. And in the United
States, Alabama, Arkansas, Indiana, Tennessee and Wisconsin have
banned kratom. Several other states are reviewing proposals to outlaw
it, Gottlieb noted.

For now, the FDA said it is working to prevent shipments of kratom
from entering the country.

"We've learned a tragic lesson from the opioid crisis: that we must
pay early attention to the potential for new products to cause
addiction, and we must take strong, decisive measures to intervene,"
Gottlieb said.

The U.S. National Institute on Drug Abuse has information on commonly
abused drugs.

SOURCE: Nov. 14, 2017, statement, U.S. Food and Drug Administration
Commissioner Scott Gottlieb, M.D.
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MAP posted-by: Matt