
Answer:
Kratom (Mitragyna speciosa) is promoted for many uses. These include increasing energy, helping with anxiety and depression, providing pain relief, and easing symptoms of opioid withdrawal. However, these potential benefits come with serious potential risks -- which have included death in several cases.
A native herb of Southeast Asia, kratom is typically sold in the U.S. as a leaf powder or leaf extract and may come as a powder, liquid, capsule, or tea. The active compounds in kratom can have opioid-like effects similar to morphine and heroin.
Safety Concerns
Due to safety concerns, the FDA has urged consumers not to use any products labeled as containing kratom, or its psychoactive compounds, mitragynine and 7-hydroxymitragynine.
An analysis of reports in the United States National Poison Data System (NPDS) between 2011 and 2018 showed that the most common adverse effects associated with the use of kratom alone were agitation (18.6%), tachycardia (16.9%), drowsiness (13.6%), vomiting (11.2%), and confusion (8.1%). Severe adverse effects included seizure (6.1%), withdrawal (6.1%), hallucinations (4.8%), respiratory depression (2.8%), coma (2.3%), and cardiac or respiratory arrest (0.6%). In the majority of these cases, kratom was taken orally as a tablet, capsule or powder (Eggleston, Pharmacotherapy 2019).
Kratom use has also been linked with liver injury in people with and without a history of liver disease (Schimmel, Drugs 2020; Botejue, Cureus 2021). In one case, a 56-year-old man with a history narrowing of the bile ducts (which can cause liver dysfunction) developed severe jaundice and acute liver failure requiring emergency treatment, which his physicians attributed to his use of kratom. It was reported he had been using kratom for pain relief on a regular basis for almost one year, although the exact form and dose were not provided and the kratom was not tested for the possible presence of contaminants that could have contributed to liver injury (Dasgupta, Transfus Apher Sci 2024).
Consuming kratom tea during pregnancy may cause withdrawal symptoms in infants(Murthy, Paediatr Child Health 2019).
Calls to National Poison Control centers in the U.S. regarding kratom have been rising dramatically. Sixty-five percent of calls received about kratom between 2011 and 2017, came in just the last two of that seven-year period. Over half (51.9%) of the incidents resulted in serious medical outcomes, including seizures, kidney failure, cardiac arrest, coma and 11 deaths. Serious adverse events and death were more likely to occur in people using kratom in addition to other substances, such as alcohol, benzodiazepines (such as Valium and Xanax), caffeine, or fentanyl (a prescription opioid drug), but at least two deaths were associated with the use of kratom alone (Post, Clin Tox 2019).
At least two deaths have been linked with one particular brand of kratom. In July 2024, the FDA warned consumers it had received a report that one individual died after using OPMS Black Liquid Kratom, although this does not prove cause and effect and no other details were provided. In September 2024, a wrongful death lawsuit was filed on behalf of a 34-year old man who, according to the coroner's report and toxicology findings, died in 2023 from "acute mitragynine (kratom) toxicity" several days after he began taking OPMS Silver Super Green Borneo Kratom Powder to help treat his chronic pain. These and other OPMS brand kratom products are currently still sold in local vape shops as well as a variety of online websites.
Be aware that kratom can interact with prescription medications. A clinical study among 12 healthy adults showed that drinking 240 mL (about 8 ounces) of kratom tea on an empty stomach 15 minutes before taking a combination of 2.5 mg of midazolam (a benzodiazepine) and 30 mg of dextromethorphan (Mucinex DM, Delsym) increased blood concentration of midazolam by about 40% to 50%. This effect was attributed to kratom's ability to inhibit intestinal CYP3A enzymes, which help break down midazolam in the body. Although this effect was considered modest, the researchers speculated that the impact of kratom may be greater if taken with drugs that are significantly metabolized by intestinal CYP3A enzymes, such as the antiviral drug saquinavir, statins including atorvastatin and lovastatin, blood pressure-lowering drugs such as nisoldipine and nicardipine, and the antianxiety drug buspirone. Kratom did not significantly impact the metabolism of dextromethorphan, suggesting that kratom may not significantly affect CYP2D6 enzyme activity. The kratom tea consumed in this study was prepared by adding 2 grams of kratom leaf powder to about 8 fl oz of boiling water and allowing kratom to steep for 3 minutes (Tanna, Clin Pharmacol Ther 2023). (See our article about supplements that affect CYP3A4 for information about other supplements that may affect these drugs.)
In 2018, numerous kratom products were recalled after being found to be contaminated with Salmonella. The FDA has also found high levels of lead in many of the kratom products.
The FDA has urged consumers not to use any products labeled as containing kratom, or its psychoactive compounds, mitragynine and 7-hydroxymitragynine.
Legality
Although not federally classified as a controlled substance, kratom is listed as a "Drug and Chemical of Concern" by the DEA, and has been classified as a Schedule 1 substance or as otherwise legally restricted or banned in several states and cities in the U.S. The FDA considers kratom to be an unsafe food additive, and it is not legally permitted to be sold as a supplement, or as an ingredient in supplements, although many kratom products remain on the market. The agency considers kratom to be a new dietary ingredient (NDI) for which there is "inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury."
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