FDA warning against Kratom strengthened

By Dr. Ananya Mandal, MDFeb 8 2018

Dr Ananya Mandal, MD

The U.S. Food and Drug Administration (FDA) has amped up its warnings against popular herbal drug kratom. The new warning mentions the deadly risks associated with kratom including a case of a teenager who hanged himself under influence.

Mitragyna speciosa,mitragyna speciosa korth (kratom) a drug from plant to a category 5 in Thailand. Image Credit: sarintra chimphoolsuk / Shutterstock

The new warning statement issued by the FDA states that the effects of this herbal concoction is yet to be understood clearly. The effects of kratom in the cases of fatalities are being investigated to see the extent of damage this drug can cause.

FDA Commissioner Scott Gottlieb, in a press release this Tuesday (6th of February 2018), said that this was a reinforcement of an earlier health advisory that was released last November. The earlier advisory stated that there was “clear data on the increasing harms associated” with kratom. This was because of the 36 deaths associated with kratom at the time. In this new statement Gottlieb said that the present death count is up to 44 deaths. He explained that the FDA has classified the substance as an opioid and this would require further “scientific analysis”. He said, “This new data adds to our body of substantial scientific evidence supporting our concerns about the safety and abuse potential of kratom… As the scientific data and adverse event reports have clearly revealed, compounds in kratom make it so it isn’t just a plant — it’s an opioid.”

Kratom is derived from a plant that grows in South east Asia. It is related to coffee and the leaves are used to make the drug. It is available at online portals and websites in the form of powder packaged within capsules or as tea. Kratom can act as a mood enhancer or as a sedative. Its effects as a stimulant or a sedative depend on the variety of the plant or on the dosage taken. It has been claimed to treat long term pain, depression and anxiety disorders effectively. It has also been used by heroin abusers who wish to step down from their addiction. It is being touted as a “non-opioid” alternative to traditional opioids. However, being an unregulated drug available for use and made by multiple manufacturers in a non-standardized manner, the quality of the drug is not assured as it its dosage, composition and packaging. This may lead to adulteration and overdosage on self-medication, says the FDA. The FDA warns that as of now the claims in favour of kratom have not been verified scientifically and the potential harms are known.

Gottlieb added in his statement that kraton has a potential for “abuse, addiction, and serious health consequences; including death.” The 36 death reports earlier, he said were reported in academic research, adverse event reports from Accident and Emergency Departments and from the reports of the Medical Examiners. Reports of the eight new cases are also to be rel;eased shortly, he said. These victims were all on multiple substances at the time of death he said. These were all illicit and harmful drugs. The teenager who hanged himself for example tested positive for kratom, alcohol and several other prescription drugs. Another person who feel out of a window under influence showed high blood levels of mitragynine. This is the main psychoactive substance that is present in kratom. Another middle aged man who died of overdose, was found to have opioids, benzodiazepines as well as kratom in his blood. Only one of the deaths was due to kratom alone states the FDA. Gottlieb said that this case was being investigated and also that it was not an absolute proof that kratom could be causing these deaths alone.

“Many of the cases received could not be fully assessed because of limited information provided,” Gottleib said, adding, “a few cases raise concern that kratom is being used in combination with other drugs.” “Cases of mixing kratom, other opioids, and other types of medication is extremely troubling because the activity of kratom at opioid receptors indicates there may be similar risks of combining kratom with certain drugs, just as there are with FDA-approved opioids,” Gottlieb said.

After this statement, kratom could be facing a ban under federal law say experts. FDA sent the Drug Enforcement Administration (DEA) an “8 factor analysis” to place the drug under a schedule and reduce its free availability and increase user awareness.