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Hydroxycut products: Advice to consumers, update 3

1 July 2010

In May 2009, the TGA advised that the US Food and Drug Administration (FDA) had issued a warning to consumers to cease using US Hydroxycut products due to reports of a number of serious adverse reactions, including liver toxicity. To date, the cause of these reactions has not been identified by the FDA.

At the time, the sponsor of Australian Hydroxycut products, Export Corporation (Australia) Pty Ltd, advised the TGA that the formulations of the US and Australian Hydroxycut products were different. Precautionary reviews of Australian Hydroxycut products were undertaken by the TGA and the following products, Hydroxycut (AUST L 154243), Hydroxycut Max (AUST L 154808) and Hydroxycut Hardcore (AUST L 154647) were removed from the Australian Register of Therapeutic Goods (ARTG) for reasons that were not related to safety.

Media reports in February 2010 claimed that a case of liver toxicity in Australia is linked to the use of Hydroxycut Hardcore. Investigations by the TGA have ascertained that this case may have occurred as early as June 2008. At the time, there were no Hydroxycut Hardcore products included in the ARTG, which indicates that the product involved was most likely sourced from outside Australia.

Consumers should be aware that Hydroxycut products purchased via the internet may be sourced from overseas and may therefore contain ingredients which are not permitted in low-risk medicines in Australia.

Australian Hydroxycut products, which are marketed for indications related to energy and weight loss, carry an AUST L number on the front of the carton.

The following Hydroxycut products are currently listed on the ARTG:

  • Hydroxycut Advanced - AUST L 165418
  • Hydroxycut Max! Advanced - AUST L 166328 and 169264
  • Hydroxycut Hardcore X - AUST L 167629

If health professionals or consumers suspect that an adverse reaction to a medicine has occurred, they are encouraged to report it directly to the TGA using a "blue card" or by phoning the Adverse Medicine Events Line on 1300 134 237.

The TGA will continue to monitor the situation and take regulatory action as appropriate.