The TGA is aware that the US Food and Drug Administration (FDA) has issued a warning to consumers to cease using Hydroxycut products because of reports of a number of serious adverse reactions, including liver toxicity.
The following Hydroxycut products are currently listed on the Australian Register of Therapeutic Goods (ARTG):
- Hydroxycut (AUST L 91135 and 154243)
- Hydroxycut Max (AUST L 154808)
- Hydroxycut Hardcore (AUST L 154647)
The Australian sponsor of these products is Export Corporation (Australia) Pty Ltd. All of these products are marketed for indications related to weight loss.
Export Corporation (Australia) Pty Ltd has advised the TGA that there are differences between the US and Australian formulations of Hydroxycut products. Some of the US products contain ingredients which are not permitted in low-risk medicines listed on the ARTG. The TGA is working with the sponsor to determine whether there are any implications for Australian consumers.
The FDA is as yet unable to determine which ingredient/s in these products are implicated in these adverse reactions, or whether other factors such as the use of other medicines or the duration of use may affect the risk.
To date, the TGA has received no reports of adverse reactions similar to those reported in the US. However until the TGA has completed a safety audit of these products, consumers are advised to exercise caution when using Australian Hydroxycut products.
Australian Hydroxycut products carry an AUST L number at the bottom of the front of the carton.
Consumers should also be aware that Hydroxycut products purchased via the internet may be sourced from the US.
Consumers who have purchased US Hydroxycut products are advised to cease taking them and contact their health professional if they have any concerns.
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.