DÄ internationalArchive36/2009Chinese Slimming Capsules Containing Sibutramine Over The Internet—A Case Series: In reply

Correspondence

Chinese Slimming Capsules Containing Sibutramine Over The Internet—A Case Series: In reply

Dtsch Arztebl Int 2009; 106(36): 584; DOI: 10.3238/arztebl.2009.0584b

Müller, D

LNSLNS We take it that Wiebrecht agrees with us, that drug preparations and food supplements of dubious quality are readily available and that internet trading is an obstacle to tighter controls. In this context I refer readers to the press release issued by Germany's Federal Institute for Drugs and Medical Devices that was published simultaneously with our article (1).

The preparation that we reported on was advertised as a "purely plant based (herbal)" product, to which a high dose of a synthetic substance had been added intentionally without being declared. The product thus met neither the criteria for a "traditional drug" (in terms of its ingredients) nor for a proprietary medicinal product (in terms of pharmaceutical law). It was falsely declared as a food supplement and was thus not subject to any licensing procedures. In my opinion, this practice is not the result of the EU Directive on the licensing of traditional drugs; improvement by means of "pragmatic" licensing conditions or laws is therefore impossible.

Poisons centers have registered a notable increase in patients presenting to emergency outpatient clinics with clinical signs of overdose and side effects of medical drugs after ingestion of seemingly harmless slimming capsules. In the samples in our article, the dose of sibutramine-which requires a license for distribution in Germany—in each capsule was nearly twice the recommended maximum daily dose that is licensed for use in the country. Further, the monitoring authorities were informed (toxicovigilance). Our article's objective was to highlight the possibility that such products have been consumed, in order to be able to identify these substances by means of a targeted medical history in patients with particular clinical symptoms, and in order to consult a poisons center and initiate toxicological analyses if required.

We do not by any means advocate the wholesale discreditation of phytotherapeutic drugs, neither do we intend wholesale condemnation of Chinese drug preparations; this was not the subject of our article. We agree with Wiebrecht's demand for valid certification with a complete declaration of ingredients (and thorough pharmacological/pharmaceutical testing). DOI: 10.3238/arztebl.2009.0584b


Dr. med. Dieter Müller
Giftinformationszentrum Nord; Universitätsmedizin Göttingen
Robert-Koch-Straße 40, 37075 Göttingen
dmueller@med.uni-goettingen.de

Conflict of interest statement
The authors of both contributions declare that no conflict of interest exists according to the guidelines of the International Committee of Medical Journal Editors.
1.
Bundesinstitut für Arzneimittel und Medizinprodukte. Pressemitteilung 04/09: BfArM warnt vor einem dubiosen Produkt zur Gewichtsabnahme aus dem Internet. www.bfarm.de (23.05.2009).
2.
Mueller D, Weinmann W, Hermanns-Clausen M: Chinese slimming capsules containing sibutramine over the internet—A case series [Sibutramin in chinesichen Schlankeitskapseln. Eine Fallserie]. Dtsch Arztebl Int 2009; 105(13): 218–22.
1. Bundesinstitut für Arzneimittel und Medizinprodukte. Pressemitteilung 04/09: BfArM warnt vor einem dubiosen Produkt zur Gewichtsabnahme aus dem Internet. www.bfarm.de (23.05.2009).
2. Mueller D, Weinmann W, Hermanns-Clausen M: Chinese slimming capsules containing sibutramine over the internet—A case series [Sibutramin in chinesichen Schlankeitskapseln. Eine Fallserie]. Dtsch Arztebl Int 2009; 105(13): 218–22.