GoLean Detox Capsules Pose Serious Risk to Health, TGA Warns

| By | TGA, warning letter

GoLean Detox capsules pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested a product labelled GoLean Detox capsules and found that:

  • the capsules contain the undeclared substances sibutramine and phenolphthalein.

Consumers are advised that:

  • Sibutramine is a prescription-only medicine (which was the active ingredient in Reductil). It was withdrawn in October 2010 after a study showed an increased risk of major cardiac events.
  • Phenolphthalein is a prescription-only (S4) drug previously marketed as an oral laxative, withdrawn from sale in many markets in the late 1990’s due to concerns over its carcinogenicity with long term use.

The supply of GoLean Detox capsules containing undisclosed sibutramine and phenolphthalein is illegal.

GoLean Detox 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.

Information for consumers

  • Stop taking GoLean Detox capsules and take any remaining capsules to your local pharmacy for safe disposal.
  • If you have any concerns arising from your use of this product, consult your health care practitioner.

Action the TGA is taking

The TGA is working with the Australian Border Force (ABF) to help stop future shipments GoLean Detox capsules from entering Australia.

If these capsules are found at the border by the ABF they will be seized and destroyed.

The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas Internet sites and has produced a short video on the risks associated with buying medicines and medical devices online. Products purchased over the Internet:

  • may contain undisclosed and potentially harmful ingredients
  • may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.
SOURCE: tga.gov.au
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