A ‘natural’ weight loss product containing sibutramine

For consumers who want to lose weight, using a product claiming to make that weight loss easier may be an attractive option. Herbal products are often perceived as safe because they are ‘natural’. However, these products are not free of risks. Herbal products themselves can be a cause of adverse drug reactions but these products can also be adulterated with active pharmacological ingredients. A recent Dutch study determined whether herbal food supplements for weight loss on the Dutch market contained active pharmacological ingredients with weight loss properties. This study found that in 50 samples collected from August 2004 to May 2013, in 24 samples sibutramine, desmethylsibutramine (DMS), didesmethylsibutramine (DDMS), rimonabant, sildenafil, and/or the laxative phenolphthalein were identified. Some samples contained multiple active pharmacological ingredients. The presence of these ingredients was not stated on the label. In addition, several other studies have identified sibutramine and other active pharmacological ingredient in supposedly ‘natural’ products. The Netherlands Pharmacovigilance Centre Lareb, located in ’s Hertogenbosch in the Netherlands, collects and analyzes reports of adverse drug reactions (ADRs). By maintaining the reporting system for ADRs, Lareb monitors the safety of medicines and vaccines in the Netherlands. In addition to monitoring the safety of registered drugs and vaccines, healthcare professionals and the general public can also report non-registered herbal products and food supplements including vitamins. In the Netherlands, herbal products can obtain marketing authorization through the Dutch Medicines Evaluation Board (MEB) in the case that the same efficacy and safety data are available as for ‘regular’ drugs. A manufacturer can also apply for a marketing authorization as a ‘traditional herbal drug’ through the MEB, meaning that the efficacy of these products is assessed not by clinical testing but on the basis of a long history of use and experience. If an herbal product is not registered through the MEB, it falls under the Dutch Commodities Act. Information on the reported ADRs of these products under the Dutch Commodities Act is shared with the Netherlands Food and Consumer Product Safety Authority (NVWA). At present, the database of Lareb contains 39 reports about unregistered slimming products, of which 9 were suspected of being adulterated with an illegal active pharmacological ingredient. In an additional 7 cases, high dosages of caffeine were added to weight loss products containing cactus, Aurantii pericarpium (bitter orange), Yerbamate (leaves), Guarana (Seeds), and Kola nut (seeds). For products where such a suspicion arises, Lareb requests the reporter (either a healthcare professional or consumer) to send a