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.
The FDA issued a public health advisory on Tuesday over the use of kratom, an unapproved botanical substance that originates from Thailand, Malaysia, Indonesia and Papua New Guinea. "In response to a request from the Drug Enforcement Administration (DEA), the FDA has conducted a comprehensive scientific and medical evaluation of two compounds found in kratom".
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". Because it produces symptoms, such as euphoria, similar to opiates, it is also used recreationally.
Along with opioid withdrawal, kratom is also believed to relieve fatigue, pain, cough and diarrhea. The warning comes amid an increase in popularity in the USA, where kratom is touted as a treatment for pain, anxiety, depression and even as an opioid alternative. The DEA had planned to list kratom as a schedule 1 drug, which means it is a drug with no now accepted medical use and a high potential for abuse.
Because kratom is largely unregulated, "you never know the real strength, ingredients, or how it's prepared", says Chris Barth, who used the medication Suboxone to recover from a pain pill addiction a decade ago.
On Nov. 14, 2017, FDA Commissioner Scott Gottlieb, MD, issued a statement regarding the risk of using kratom.
Gottlieb said the FDA is treating kratom as an unapproved drug and also has taken action against kratom-containing dietary supplements.
The regulator said there are now no approved therapeutic uses of kratom, which is linked to serious side effects such as seizures and liver damage. Hundreds of shipments have been detained and product has been seized and destroyed.
Still, more than 340 million packages reach the USA every year. But the agency backtracked after public outcry and pressure from some members of Congress.
"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. "From the outset, the FDA must use its authority to protect the public from addictive substances like kratom, both as part of our commitment to stemming the opioid epidemic and preventing another from taking hold".