Hydroxycut products: Advice to consumers, update 2

17 February 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.

Recent media reports have claimed that a case of liver toxicity in Australia is linked to the use of Hydroxycut Hardcore. Further investigations are being conducted in light of these media reports. The TGA had not received any reports of liver injury prior to these media reports, and has yet to receive detailed information about the particular case. As a result the TGA has been unable to ascertain whether the patient who was reported in the media to have suffered liver toxicity took the Australian or the US product.

Until the TGA has completed its investigations, consumers are advised to exercise caution when using Australian Hydroxycut products.

Consumers should be aware that Hydroxycut products purchased via the internet may be sourced from the US and may 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 - AUST L 91135
  • Hydroxycut Advanced - AUST L 165418
  • Hydroxycut Max! Advanced - AUST L 166328
  • Hydroxycut Hardcore X - AUST L 165292 and 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.