FDA warns of 'deadly risks' of the herb kratom, citing 36 deaths

Modesto Morganelli
Novembre 14, 2017

The FDA noted the risk for addiction and misuse.

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".

Kratom, a plant grown naturally in countries including Thailand and Malaysia, is widely sold in smoke shops and other locations as a powder that can be used in tea to slow the effects of opioid withdrawal. Because it produces symptoms, such as euphoria, similar to opiates, it is also used recreationally.

Later in 2016, the DEA asked that the FDA provide a scientific and medical evaluation of the drug.

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".

Along with opioid withdrawal, kratom is also believed to relieve fatigue, pain, cough and diarrhea. Anita Gupta, an osteopathic anesthesiologist and licensed pharmacist, has expressed concern about an increase in the use of kratom among her chronic pain patients. 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. 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. "There have been reports of kratom being laced with other opioids like hydrocodone".

"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 FDA has exercised jurisdiction over kratom as an unapproved drug, and has also taken action against kratom-containing dietary supplements. Hundreds of shipments have already been detained and many are seized.

While it's very important to strengthen border enforcement, "the challenge is akin to pushing the tide back into the ocean", says Sharfstein. 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.

"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.

"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".

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