The Spanish Medicines Agency withdraws the product HHS A1 L-Carnitine Lepidum capsules

The Spanish Agency for Medicines and Health Products (AEMPS) has been aware, through several complaints, of the marketing of the product HHS A1 L-Carnitine Lepidium capsules by the HHS company (Türkiye), as indicated on its labeling.

HHS A1 L-Carnitine Lepidium capsules are marketed as a food supplement, despite not having been notified of its placing on the market to the competent authorities, failing to comply with the provisions of current regulations for this type of products.

Furthermore, 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 exercising a pharmacological action, which gives it legal status. of medicine. This substance is not declared on its labeling, which deceptively indicates a series of ingredients of plant origin, giving false information about its safety, which could cause serious damage to the health of people who consume it.

Sibutramine is an anorectic active ingredient (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). Additionally, sibutramine produces an increase in heart rate and blood pressure, which can be clinically significant in some patients, with cases of arrhythmias, ischemic heart disease and serious vascular accidents having been recorded 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 medications intended for the treatment of obesity, however, its marketing was suspended in the European Union because its consumption was associated with serious cardiovascular adverse effects, as reflected in the informative note from the AEMPS on sibutramine (Reductil®) , published on January 21, 2010.

Considering the aforementioned, as well as that the product HHS A1 L-Carnitine Lepuidum capsules has not been subject to evaluation and authorization prior to marketing by the AEMPS, the director of the Agency, in the exercise of its powers. , has resolved to adopt the following precautionary measure:

The prohibition of marketing and the withdrawal from the market of all copies of the aforementioned product.

The AEMPS recommends that HHS A1 L-Carnitine Lepidum capsules not be consumed due to the serious associated adverse effects.

The permanently updated information on all medicines authorized and controlled by the AEMPS is available on the Agency's website, www.aemps.gob.es, within the online Medicines Information Center ( CIMA ) section.