The Spanish Agency of Medicines and Medical Devices (Aemps) has banned the sale and ordered the withdrawal from the market of all units of about twenty slimming products for containing sibutramine, an active ingredient suspended in the EU since 2010 due to its association with several serious adverse effects.
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These products are Slim U; Slim U Pro; P57 Hoodia; Bikini Siluet Perfect; Slim 24; 14 Día; Fatzorb; AB Slim; Get Lean; Slimina; Burn and Slim; Body Slim; Black Panther; Aphrodite Thermoslim Coffe; Aphrodite Plus; Aphrodite LipoDetox; Aphrodite Green Plus; Aphrodite Forte Plus; Aphrodite Forte; Li Da Ultra; Pineapple Slimming Peptide and Pezo Mega.
The agency dependent on the Ministry of Health has decided to ban their sale and withdraw all units of these products from the market after becoming aware, through the Consumption, Environment and Doping Section of the General Police Judicial Commissariat within the framework of Operation Triki, that they were being marketed.
As explained in a statement, the Official Medicines Control Laboratory (LOCM) of Aemps has carried out analyses confirming that all of them contain sibutramine and that some – Fatzorb, AB Slim, Get Lean, Slimina, Burn and Slim, Body Slim and Black Panther – also contain phenolphthalein.
This gives them the status of medicines, but they have not been evaluated or authorized by the agency, which denounces that these substances are not even listed on the supplement labels, which “are presented as natural and hide their true composition from the consumer.”
Sibutramine was suspended in the EU due to its association with serious cardiovascular adverse effects
Sibutramine is an anorectic active ingredient (appetite suppressant) that provides a feeling of satiety and also increases caloric expenditure.
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It also causes an increase in heart rate and blood pressure that can be clinically significant in some patients, among whom cases of arrhythmias, ischemic heart disease, and serious vascular accidents have been recorded.
Other adverse effects derived from its consumption include dry mouth, headache, insomnia, or constipation, in addition to having many interactions with other medications.
This substance was part of the composition of prescription medicines intended for the treatment of obesity, but its marketing was suspended in the EU in 2010 due to its association with these serious cardiovascular adverse effects.
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Phenolphthalein, on the other hand, is a stimulant laxative active ingredient that increases intestinal motility and inhibits the absorption of electrolytes and water.
Its main risks are precisely related to excessive loss of fluids and electrolytes, intestinal protein loss, hypocalcemia, and malabsorption due to excessive intestinal hypermotility.
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