FDA Adds to Kratom Safety Concerns, Linking Drug to Multistate Salmonella Outbreak

In addition to the outbreak, kratom is expected to have a similar risk of addiction, abuse and death as an opioid, the agency announced earlier this month.

The Centers for Disease Control (CDC) and US Food and Drug Administration (FDA) are investigating a multistate outbreak of salmonellosis from a rare strain of Salmonella I 4,[5],12:b:- recommending that individuals do not consume kratom in any form because it could be contaminated.

On February 6, the FDA classified kratom, a botanical substance widely used as a painkiller, despite agency approval, as an opioid. In the midst of the approval, Scott Gottlieb, FDA commissioner, referenced the FDA’s concerns about the plant substance and its health consequences, which could include death.

Gottlieb noted that many of the reports the FDA received regarding the substance weren’t fully assessed due to a limited amount of available information.

The agency emphasizes there are no FDA-approved uses for kratom, and it's not safe for any medical use, including for the treatment of opioid withdrawal symptoms. The agency has received reports concerning the safety of kratom, including the deaths associated with it.

"There’s no safe kratom product,” Scott Gottlieb, MD, FDA Commissioner said in a statement. “In addition to this outbreak, kratom is an opioid; expected to have similar risk of addiction, abuse and death.”

In previous statements, Gottlieb said the FDA needs to weigh all available evidence and ask whether the use of kratom could increase the opioid epidemic, yet he also acknowledged that if the proponents are right, kratom could be used as an alternate tool to treat the addiction.

Even though kratom is legal now, 7 states and select counties have banned the drug.

"Cases of mixing kratom, other opioids, and other types of medication are 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.

Earlier this month, the FDA linked kratom to 44 deaths since 2011. The agency recently developed a novel scientific analysis using a computer model which demonstrated stronger evidence of kratom compounds' opioid properties, which can lead to serious side effects like seizures and depression. The data adds to the FDA's evidence supporting the safety concerns and abuse potential of kratom, Gottlieb said.

As of February 16, there have been 20 states to report that 28 people are infected with the outbreak strain, 11 people have been hospitalized and no deaths have been reported. Those ill range in age from 6—67 years.

The CDC reports that the epidemiologic evidence collected indicates that products reported to be kratom or contain kratom are a likely cause of the outbreak. Whole genome sequencing performed on ill isolates are closely related genetically, meaning that people in the outbreak are more likely to share a common source of infection.

In health official conducted interviews, ill individuals were asked about the foods they ate and other exposures before they became ill. Eight of the 11 people, 73%, reported consuming kratom in pills, capsules, powder or tea.

Health officials have not identified any common brands or suppliers of products containing kratom associated with this outbreak.

Due to the Salmonella bacteria that causes the foodborne illness salmonellosis, those infected develop diarrhea, fever and abdominal cramps. The illness usually lasts 4—7 days, however, an unusually high rate of cases have been hospitalized in this current outbreak.

“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. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence,” he wrote in a November 17 statement.

Related Coverage >>>

FDA Grants Lofexidine Priority Review for Opioid Withdrawal Treatment

FDA Grants Marketing to Opioid Withdrawal Device

FDA Rejects Intellipharmaceutics Rexista