The Spanish Agency for Medicines and Health Products (AEMPS) has banned marketing and has requested the withdrawal of the market in a precautionary way of the ‘bikini forte’ capsules To lose weight after confirming that they contain sibramine, an active substance that can cause arrhythmias, ischemic heart disease and serious vascular accidents, and whose presence is not declared in the labeling.
A product not authorized by the AEMPS
This was indicated by the AEMPS this Friday in a statement in which he explains that it has been the General Judicial Police Police Station that has reported The commercialization of this productthat the agency had not authorized. Analysis carried out by the Official Control Laboratory of the AEMPS have found in its composition a sufficient amount of sibtramine to restore, correct or modify a physiological function exercising a pharmacological action, which gives it the legal condition of medication.
In labeling, It is indicated in a deceptive way That the product is formed by a series of products of plant origin and amino acids, without referring to sibtramine, so it gives false information about its safety.
Risk of arrhythmias, heart disease and serious vascular accidents
Sibtramine is an anorexigen active substance (appetite suppressor) that provides a feeling of satiety and also produces An increase in caloric expenditure (Attenuates the adaptive decrease in basal metabolism during weight loss). It also increases heart rate and blood pressure, which can be clinically significant in some patients, having recorded cases of arrhythmias, ischemic heart disease and serious vascular accidents with their consumption.
Among the adverse effects that may occur with their consumption also stand out Dry mouth, headache, insomnia, constipationamong others. Similarly, it has a large number of interactions with other medications.
Sibbtramine was part of the composition of recipe medications destined to the treatment of obesity, whose marketing in the European Union was suspended in 2010 by associating its consumption for serious adverse effects of cardiovascular type.
