FDA raises concerns about use of kratom for opioid addiction

FDA commissioner Scott Gottlieb speaks to members of the USA TODAY Editorial Board in August 2017

FDA commissioner Scott Gottlieb speaks to members of the USA TODAY Editorial Board in August 2017

In August 2016, the Drug Enforcement Agency moved to make kratom a Schedule I drug, a substance that has "no now accepted medical use and a high potential for abuse".

Consumers are increasingly using the supplement, which comes from a plant in Southeast Asia, for pain, anxiety and depression, as well as symptoms of opioid withdrawal. Additionally, the FDA is aware of reports of 26 deaths associated with the use of kratom-containing products, and that there have been reports of kratom being laced with other opioids like hydrocodone.

Rather, he said, evidence shows that the herb has similar effects to narcotics like opioids, "and carries similar risks of abuse, addiction and, in some cases, death". "It's not surprising that kratom is often taken recreationally by users for its euphoric effects, [however, ] 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", he wrote.

Along with opioid withdrawal, kratom is also believed to relieve fatigue, pain, cough and diarrhea.

The group has said categorizing kratom as an illegal substance would stymie medical research into its potential therapeutic uses. The FDA evaluated 2 compounds found in kratom, according to the statement however, there was no mention of the evaluation's outcomes in the statement.

"The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products", said FDA Commissioner Scott Gottlieb, MD, in a November 14 statement.

The fact Gottlieb is speaking to the investigations staff is significant because "if they find people here who are opening the gates to these drugs, there may be opportunities for the FDA to investigate at a high level", says Joshua Sharfstein, former principal deputy FDA commissioner in the Obama administration. Hundreds of shipments have already been detained and many are seized.

Still, more than 340 million packages reach the US every year.

"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", said Gottlieb in his prepared remarks. But the agency backed away from that plan last October after a flood of public complaints including a letter signed by 62 members of Congress and a protest at the White House organized by the American Kratom Association.

"From the outset, the FDA must use its authority to protect the public from addictive substances like kratom", Gottlieb wrote, "both as part of our commitment to stemming the opioid epidemic and preventing another from taking hold".