November 14, 2017
The US Food and Drug Administration (FDA) is warning against the use of kratom, a plant with opioid properties, noting it is addictive and has been linked to 36 deaths.
In a public health advisory issued on November 14, FDA Commissioner Scott Gottlieb, MD, said that the FDA had been and would continue to take steps to "actively prevent shipments of kratom from entering the US.
"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," Dr Gottlieb said.
Kratom is derived from the leaves from the kratom tree (Mitragyna speciosa), which is native to Thailand, Indonesia, and Papua New Guinea. Its popularity is increasing in the United States, with users claiming the botanical helps treat pain, anxiety, depression, and, more recently, opioid withdrawal.
But it is an unapproved drug and is being illegally promoted for those conditions, said Dr Gottlieb. "I understand that there's a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders," he said in the advisory. "But the FDA has a science-based obligation that supersedes popular trends and relies on evidence," said Dr Gottlieb.
Risk of Abuse, Addiction, Death
The FDA's drug review process could provide the evidence kratom is useful, he said. Current evidence shows that kratom "has similar effects to narcotics like opioids and carries similar risks of abuse, addiction, and in some cases, death," Dr Gottlieb said.
Calls to US poison control centers associated with kratom increased tenfold from 2010 to 2015, and the FDA has received reports of at least 36 kratom-associated deaths. The agency is also aware of reports of kratom being "laced with other opioids, like hydrocodone," he noted.
The FDA is not the first federal agency to attempt to regulate kratom. In August 2016, the US Drug Enforcement Administration (DEA) threatened to add kratom's active ingredients ? the opioids mitragynine and 7-hydroxymitragynine ? to its list of controlled substances, making it a Schedule I drug.
However, the FDA did not solicit public input, and critics claimed the FDA was attempting to circumvent the traditional regulatory process.
Fifty-one members of the US House wrote to the DEA's acting administrator and to the director of the White House Office of Management and Budget soon after the DEA's announcement, stating that its action was potentially illegal and that it could stop much-needed research.
Sen. Orrin Hatch (R-UT), along with eight other senators, also urged a reconsideration, as did Senators Cory Booker (D-NJ), Ron Wyden (D-Ore), and Kirstin Gillbrand (D-NY) in a separate request.
The DEA put the scheduling on hold, and the issue has not been revisited since. The FDA advisory said that it had conducted, at the DEA's request, a "comprehensive scientific and medical evaluation of two compounds found in kratom."
Multiple states, which maintain their own lists of controlled substances, have made kratom illegal. These include Arkansas, Indiana, Tennessee, and Wisconsin.
Several other states are considering banning the substance, according to Speciosa.org, a website that is apparently maintained by the Botanical Education Alliance and the American Kratom Association.
Kratom is a controlled substance in 16 countries, including Thailand and Malaysia, according to the FDA.
More Questions Than Answers
Kratom is being studied at several US universities. Walter Prozialeck, PhD, chairman of the Department of Pharmacology at the Chicago College of Osteopathic Medicine, Midwestern University, in Illinois, and colleagues conducted reviews in 2012 and 2016 that showed that kratom likely has some potential benefits.
But Dr Prozialeck told Medscape Medical News that many questions about safety and effectiveness have not yet been answered. He also noted that research would likely come to a standstill if the DEA classified kratom as a Scheduled I substance.
Dr Gottlieb said the FDA was not trying to shut down research. He said that, on the contrary, he invited scientists and manufacturers to conduct the required studies and to involve both the FDA and the DEA in the evaluation process.
"To those who believe in the proposed medicinal uses of kratom, I encourage you to conduct the research that will help us better understand kratom's risk and benefit profile, so that well studied and potentially beneficial products can be considered," said Dr Gottlieb.
In the meantime, the FDA will continue to seize and destroy kratom products found in the mail, he said.
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SOURCE: Medscape, November 14, 2017.