Marketers have been selling kratom, a plant grown in parts of Asia, as a treatment for a variety of conditions including pain, anxiety, and depression. In some cases, kratom is mixed with opioids like oxycodone, the ingredient in OxyContin, according to the agency.
Kratom is a naturally growing plant in Thailand, Malaysia, Indonesia and Papua New Guinea, and is being marketed as a "safe" treatment option for certain diseases, including opioid addiction, the FDA said. Anita Gupta, an osteopathic anesthesiologist and licensed pharmacist, has expressed concern about an increase in the use of kratom among her chronic pain patients.
"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. In his statement, he wrote that calls to USA poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year. Gottlieb said kratom has been associated with "serious side effects like seizures, liver damage and withdrawal symptoms". Today, kratom leaves are ground into pills and powders, and sold as a dietary supplement. It can be found in head shops and online. Between February 2014 and July 2016, the DEA said, almost 247,000 pounds of kratom were seized.
The FDA public health advisory on kratom follows the Drug Enforcement Administration's reversal or at least delay of plans to classify kratom as a controlled substance on the same level as heroin and LSD. After a public outcry, including letters from members of the House of Representatives and the Senate, the DEA withdrew its intent make it Schedule I. Instead, it opened a public comment period to react to possible scheduling, which closed in December 2016. Since that time, the DEA has taken no action. 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.
Despite Tuesday's warning about the risks of kratom an FDA spokeswoman said the agency's scientific review is ongoing.
There have been 36 deaths linked to the use of kratom-containing products, the FDA said, adding that the substance is also being laced with other opioids like hydrocodone for marketing purposes.
"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".