Translation of a-t 2025; 56: 53-4

BfArM issues warning about food supplements containing kratom

Kratom is obtained from the pulverised leaves of the southeast Asian evergreen tree called kratom (Mitragyna speciosa) and advertised as a food supplement to treat pain, inflammation, cough, anxiety and depression and other conditions, and is also used to treat opioid withdrawal symptoms.^1,2 Overall, the herbal product, which is also known as herbal speed and is not marketed as a medicinal product, is classed by the Mayo Clinic in the US as "unsafe and ineffective".² The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is now warning about potential harmful neurological effects, including dependence and withdrawal syndrome, and liver and kidney damage, and notes that there have been deaths linked to kratom.¹ There is no specific information that could shed light on the threatening consequences of taking it in the short BfArM communication (see also misoprostol, a-t 2025; 56: 54-5). Seven years ago, however, we advised about 44 suspected reports of deaths that had been submitted to the US drug authority, the FDA, at that time. The authority noted that kratom contains alkaloids that have significant structural similarities with opioid analgesics and that the main alkaloid, mitragynine, had 13 times the potency of morphine in terms of its opioid-like effects (a-t 2018; 49: 55-6). In our view, it would therefore be logical to list kratom or the component mitragynine as a controlled substance for reasons of preventative consumer protection, as is the case in Switzerland,³ for example. In Germany, however, the competent state authorities together with BfArM have not even been able to decide whether kratom should be classed as a food supplement or a medicinal product that requires authorisation. At the start of the year, we pushed for the legal distinction between food supplements and medicinal products to be simplified as a matter of urgency, so decisions of this type do not continue to lead to an authority employment generation programme lasting years, delaying long overdue measures to minimise risks (a-t 2025; 56: 9-10), –Ed.

©  arznei-telegramm (Berlin/Germany), July 2025, protected by copyright laws.