An Indonesian slimming drug with undeclared ingredients causing harm

药物警戒 业务 执行 食品安全 危害 西布曲明 欧洲联盟 医学 药品 法学 药理学 政治学 国际贸易 肥胖 病理 减肥 内科学
作者
Sonja van de Koppel,Corine Ekhart,Chantal Roelen,Dana Ohana,Martin Kooijman,Florence van Hunsel
出处
期刊:Drug Testing and Analysis [Wiley]
卷期号:15 (6): 695-700 被引量:2
标识
DOI:10.1002/dta.3460
摘要

This paper reports the presence of undeclared drugs in the herbal slimming supplement Sulami®. The four cases of the adverse drug reactions related to Sulami® were reported to the Dutch Pharmacovigilance Centre (Lareb) or the Dutch Poisons Information Centre (DPIC). The analysis of all four collected samples revealed adulteration with sibutramine and canrenone. Both drugs can cause serious adverse drug reactions. From a legal point of view, it is clear that Sulami® does not meet the legal requirement for safety. As defined in the European General Food Law Regulation, food business operators are responsible for food safety. This also applies to online store owners who sell herbal preparations. Thus, it is clear that it is forbidden to sell Sulami® on the European and Dutch market. Collaboration between involved national authorities makes it possible to identify risky products. This allows the nationally responsible regulators to take targeted action. They can call on users to report sell points what makes it possible to arrest the sellers and confiscate the dangerous products. Beyond the national, also, the European enforcement organizations should take legal measures where possible, to protect public health. The Heads of Food Safety Agencies Working Group on Food Supplements "an Initiative on European level" is a good example of efforts to improve consumer safety.
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