The AEMPS prohibits the marketing of various slimming products that contain sibutramine, a substance not declared on their labels and potentially dangerous to health, as it can cause arrhythmias and serious cardiovascular events.
The Spanish Agency for Medicines and Medical Devices (AEMPS) has banned the sale of several fat-burning products and ordered them to be immediately withdrawn from the market because, according to analyses carried out by the Official Control Laboratory of the AEMPS, they contain sibutramine in a quantity sufficient to exert a pharmacological action, which grants them the legal status of medicines. However, this substance is not declared on their labels, providing misleading information about their safety and representing a significant risk to the health of those who consume them.
The products covered by the ban are: Soraya Capsules, HHS Kuka Coffee, Soraya Slim Coffee Coffee, Lipo Solution and Detox Tea. Sibutramine is an anorectic agent (appetite suppressant) that induces a feeling of satiety and also increases caloric expenditure by counteracting the adaptive decrease in basal metabolism during weight loss. In addition, its consumption can increase heart rate and blood pressure, which may be clinically relevant in some patients.
In fact, cases of arrhythmias, ischemic heart disease and serious strokes have been reported in association with its use. Other side effects include, among others, dry mouth, headache, insomnia and constipation. Sibutramine also has numerous interactions with other medications.
Serious cardiovascular effects associated with these ‘fat burners’
This active ingredient was found in prescription drugs intended for the treatment of obesity, but its marketing was suspended in the European Union due to its link with serious cardiovascular adverse effects, as mentioned in the AEMPS information note on sibutramine (Reductil), published on January 21, 2010.
In the specific case of the Detox Tea product, the presence of sildenafil was also detected, an active substance indicated to restore erectile function by increasing blood flow to the penis, by selectively inhibiting the enzyme phosphodiesterase 5 (PDE-5). PDE-5 inhibitors are contraindicated in patients with conditions such as acute myocardial infarction, unstable angina, heart failure, uncontrolled arrhythmias, hypotension, uncontrolled arterial hypertension, history of ischemic stroke, severe liver failure and hereditary degenerative disorders of the retina, such as retinitis pigmentosa.
Consumption of these products can trigger adverse reactions of varying severity, such as acute myocardial infarction, unstable angina, ventricular arrhythmia, palpitations, tachycardia, etc.
Furthermore, these products present multiple interactions with other medications, and their consumption can trigger adverse reactions of varying severity, especially cardiovascular, such as acute myocardial infarction, unstable angina, ventricular arrhythmia, palpitations, tachycardia, stroke, and even sudden cardiac death, with a higher incidence in patients with cardiovascular risk factors for whom their use would be contraindicated.
Given the high associated risk and considering that these products have not undergone prior evaluation and authorization by the AEMPS, the Agency has decided to prohibit their marketing and request their withdrawal from the market, after receiving a report in the context of the Butterfly operation carried out by the Consumer Group of the Central UDEV of the General Commissariat of Judicial Police on the marketing of the aforementioned products.
Source: Spanish Agency for Medicines and Health Products (AEMPS)
