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Mitragyna speciosa, commonly known as kratom, is a tropical plant of the Rubiaceae family, native to Thailand, Indonesia, and Malaysia. The leaves contain several active alkaloids, primarily mitragynine and 7-hydroxymitragynine, which act as partial agonists at mu opioid receptors and influence adrenergic and serotonergic pathways.

At low doses, kratom enhances alertness and performance and induces mild euphoria in humans. At higher doses, it produces sedative and analgesic effects similar to those of opioids. Traditionally, kratom has been used as a stimulant and analgesic during physical labour, for pain relief, and to treat diarrhoea.

In Western countries, patients are increasingly self-medicating with kratom for chronic pain, anxiety disorders, and opioid withdrawal management.

Toxicological concerns focus on the abuse potential of kratom, particularly with high or prolonged use. Tolerance and dependence may develop, with withdrawal symptoms resembling those of opioids. Acute adverse effects include nausea, vomiting, constipation, dizziness, drowsiness, and, rarely, seizures or hepatotoxicity.

Notably, the high affinity of 7-hydroxymitragynine for opioid receptors significantly contributes to the addictive potential of kratom. Other documented risks include interactions with other central nervous system depressants and potentially life-threatening respiratory depression when combined with opioids.

Kratom is often promoted online as a natural remedy for pain, anxiety, and depression. Despite its growing popularity, it carries serious health risks, including dependency and potential liver and kidney damage. Kratom is not approved for medical use in Germany.

According to a press release from the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn, Germany, the agency issued a strong warning against using kratom without medical supervision.

Safety Profile

All pharmaceutical products sold in Germany must undergo a regulatory approval process to assess their efficacy, safety, and quality. Authorities such as the BfArM and the European Medicines Agency grant authorisation only after a positive benefit-risk ratio is demonstrated. However, no such approval exists for kratom. To date, there has been no drug approval or sufficiently conclusive studies proving its safety and efficacy. The consumption of kratom carries a personal risk, which can be significant.

According to the BfArM, animal and human studies indicate that kratom can have adverse neurologic effects. Reports of addiction, sometimes with severe withdrawal symptoms, as well as liver and kidney damage, are particularly concerning. Physicians have also reported deaths associated with the use of kratom.

The National Institute on Drug Abuse in the US has reported serious side effects and deaths associated with kratom, often in combination with other substances.

What makes this more challenging is that consumers often cannot determine the actual content of the active ingredients in kratom products. Studies have shown that mitragynine, the primary active compound, can vary widely in concentration. This variability makes accurate dosing difficult and increases the risk for side effects.

In addition, certain kratom preparations may be contaminated with other substances, further increasing the potential health risks.

Marketing and Regulatory

Another growing concern is the marketing of kratom. Online retailers often promote it with health-related claims, such as pain relief or treatment for depression. Under German pharmaceutical law, such claims can result in a product being legally classified as a medicinal product, even if it is initially sold as an herbal dietary supplement.

What happens after the warning? The BfArM noted that monitoring of pharmaceutical trade in Germany falls under the responsibility of individual state authorities. These authorities assess, on a case-by-case basis, whether a product qualifies as a medicinal product that requires approval. Once such a classification is obtained, kratom may no longer be sold without appropriate approval.

The BfArM can only act if a state authority submits a formal request for review under Section 21, Paragraph 4 of the German Medicines Act. According to the agency, it is in close communication with the state regulators. Several states have already implemented measures or are planning to restrict the availability of kratom to ensure consumer safety.

This story was translated from Medscape’s German edition.