AEMPS is recalling HHS A1 L-Carnitine Lepidum Capsules.

Category: drugs for humans, illegal drugs
Reference: ICM (MI), 01/2024

The Spanish Agency for Medicines and Health Products (AEMPS) learned through several complaints about the marketing of the product. HHS A1 L-carnitine Lepidium capsules by HHS (Türkiye) as indicated on its labeling.

HHS A1 L-Carnitine Lepidium capsules are sold as a dietary supplement despite the fact that they have not been notified of its placing on the market by the competent authorities, which is not in accordance with the provisions of the current regulations for this type of product.

In addition, according to analyzes carried out by the AEMPS Official Control Laboratory, the above-mentioned product contains the active substance sibutramine in sufficient quantity to restore, correct or modify physiological function through pharmacological action, which gives it legal status. medicine. This substance is not declared on its labeling, which deceptively lists a number of herbal ingredients, giving false information about its safety, which can cause serious harm to the health of people who consume it.

Sibutramine is an anorectic active substance (appetite suppressant), providing a feeling of satiety, and also causing an increase in calorie expenditure (weakens the adaptive decrease in basal metabolic rate with weight loss). In addition, sibutramine causes an increase in heart rate and blood pressure, which may be clinically significant in some patients, and cases of arrhythmia, coronary artery disease and serious vascular accidents have been reported with its use. Other side effects that may occur while consuming it include, but are not limited to, dry mouth, headache, insomnia, constipation, etc. Moreover, it has a large number of interactions with other medications.

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

In consideration of the foregoing, and the fact that HHS A1 L-Carnitine Lepuidum Capsules has not been evaluated or approved prior to marketing by AEMPS, the Director of the Agency has decided to take the following precautions in the exercise of his authority:

Ban on commercialization and withdrawal from the market of all copies of the above-mentioned product.

AEMPS recommends against consuming HHS A1 L-Carnitine Lepidum capsules due to serious side effects.

Constantly updated information on all medicines authorized and controlled by the AEMPS is available on the Agency’s website www.aemps.gob.es in the section of the online Information Center for Medicines (CIMA).