Tuesday, January 18

The AEMPS withdraws the BIKINI fat burner due to a serious risk to the heart

The Spanish Agency for Medicines and Health Products (AEMPS) “has been made aware, through the General Commissariat of the Judicial Police of the National Police, of the marketing of the product BIKINI capsules.” As indicated on its labeling, it could have been marketed by the Trim Fast company.

BIKINI capsules is marketed as a food supplement, despite the fact that the competent authorities have not been notified of its placing on the market, in breach of the provisions of current regulations for this type of products.

According to the analyzes carried out by the Official Control Laboratory of the AEMPS, the aforementioned product contains the active substance sibutramine in sufficient quantity to “restore, correct or modify a physiological function by exerting a pharmacological action”, which gives it legal status. of medication. This substance is not declared on its labeling, which misleadingly indicates a series of products of plant origin.

What is sibutramine?

Sibutramine is a starter active anorectic (appetite suppressant) that provides a feeling of satiety and also produces an increase in caloric expenditure (attenuates the adaptive decrease in basal metabolism during weight loss).

Sibutramine causes an increase in heart rate and blood pressure, which can be clinically significant in some patients, having registered cases of arrhythmias, ischemic heart disease and serious vascular accidents with its consumption.

Other adverse effects that may occur with its consumption are, among others, dry mouth, headache, insomnia, constipation, etc. In addition, it has a large number of interactions with other medications.

Sibutramine was part of the composition of prescription drugs for the treatment of obesity, whose marketing in the European Union was suspended because its consumption is associated with serious cardiovascular adverse effects, as reflected in the AEMPS information note on sibutramine (Reductil®), published on January 21, 2010.

According to the AEMPS, “BIKINI capsules are presented as natural, hiding their true composition from the consumer and giving misleading information on their safety, being able to cause serious damages to the health of the people who consume it “.

The agency concludes that “since BIKINI capsules has not been subject to evaluation and authorization prior to marketing by the Spanish Agency for Medicines and Health Products (AEMPS), its presence in the market being illegal, the director of the AEMPS has resolved the prohibition of the commercialization and the withdrawal from the market of all copies of the aforementioned product.

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