S-shape slim capsules

Safety advisory

3 November 2011

The Therapeutic Goods Administration (TGA) is aware that some Australian consumers may have purchased the product S-shape slim capsules over the internet. The label of this product claims the ingredients to be 100% pure natural and green, and "Medicine-Edible pure botany".

However, analysis undertaken by the TGA Laboratories in Australia has confirmed the presence of therapeutic quantities of sibutramine, fenfluramine, phenolphthalein, propranolol and nifedipine in these capsules.

S-shape slim capsules packagingConsumers are advised that sibutramine was a prescription-only medicine ingredient supplied in Australia until it was withdrawn in October 2010 due to safety concerns, particularly in patients with history of cardiovascular disease. Fenfluramine was an ingredient in the medicine Fen_Phen which was withdrawn from the US market in 1997 for safety reasons. Phenolphthalein was previously used as an oral laxative, but is no longer available in Australia also due to serious safety concerns associated with its long term use. Propranolol is a prescription-only medicine ingredient mainly used for the treatment of hypertension and anxiety. Nifedipine is a prescription-only medicine ingredient used in the treatment of high blood pressure and chronic stable angina.

S-shape slim capsules have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA. In Australia, commercial supply of S-shape slim capsules is illegal.

If you have purchased S-shape slim capsules you are advised to cease using them and discard any remaining product. If you have concerns arising from your use of this product, you should consult your health care practitioner.

Consumers are again advised to exercise extreme caution about purchasing medicines from unknown overseas internet sites. Products purchased in this way may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia, and may contain undisclosed and potentially harmful ingredients.