Kratom Carries Risk Of Death, Abuse, FDA Warns

Following reports of several dozen deaths, federal regulators are warning about the potentially severe health risks associated with use of kratom, a botanical compound often advertised as a “cure” for certain general ailments. 

In a public health advisory issued on November 14, the FDA indicates that consumers should not use Mitragyna speciosa, also known as kratom, which the agency indicates has properties similar to opioid narcotics, with addictive side effects and serious overdose risks. So far, at least 36 deaths have been reported in association with the use of kratom-containing products.

The botanical substance has become more common in the U.S. in recent years. It is derived from a plant which grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. While many marketers call kratom-based products “safe,” the product can have serious side effects.

Evidence suggests that kratom risks and side effects include abuse, addiction, seizures, liver damage, withdrawal symptoms, and in some cases death, the FDA warns. Kratom acts on the same opioid brain receptors as morphine, exposing users to the risk of addiction, abuse, and dependence.

People often use kratom to treat pain, anxiety, and depression. This is problematic since the FDA has not approved kratom to treat any ailment and there are no products which contain kratom that are FDA approved. Additionally, the ailments kratom is used for are serious conditions which require the oversight of a licensed doctor.

Some users take kratom to treat opioid use or to help with withdrawal symptoms. Many reports indicate kratom products are also laced with other opioids, like hydrocodone.

“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,” FDA Commissioner Scott Gottlieb wrote. “But The FDA has a science-based obligation that supersedes popular trends and relies on evidence.”

In addition to its use as an unapproved cure-all, kratom is also taken recreationally by users because of its euphoric effects. It is considered a controlled substance in 16 countries, including Thailand, Malaysia, Australia, Sweden, and Germany. It is also banned in Alabama, Arkansas, Indiana, Tennessee, and Wisconsin.

To date, no company has attempted to work with the FDA to develop a drug that includes kratom and there are no FDA-approved therapeutic uses of kratom.

The FDA indicates calls to U.S. poison control centers regarding kratom increased 10-fold from 2010 to 2015. Hundreds of poison calls involving kratom use are made each year.

Increasing numbers of kratom shipments cross the borders each year. Because of the risk kratom poses to users, the FDA previously took action against kratom-containing dietary supplements.

The agency identified kratom products on two import alerts in 2012 and 2014 and is focusing on preventing shipments of kratom from entering the U.S. So far, the agency has detained hundreds of shipments of kratom, including thousands of pounds of raw kratom, and hundreds of thousands of bottles of prepared dietary supplements.