Therapeutic Goods Administration Australia - TGA
JOYSMI capsules pose a serious risk to your health and should not be taken.
3 April 2019
The Therapeutic Goods Administration (TGA) has tested a product labelled JOYSMI capsules and found that:
- The capsules contain the undeclared substances sibutramine, phenolphthalein and frusemide.
Consumers are advised that in Australia:
- Sibutramine is a prescription-only substance (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 It was withdrawn in October 2010 after a study showed an increased risk of major cardiac events.
- Phenolphthalein is a prescription-only substance previously marketed as an oral laxative, withdrawn from sale in the late 1990’s due to concerns over its carcinogenicity with long term use.
- Frusemide is a prescription-only substance used for the treatment of oedema and high blood pressure.
The supply of JOYSMI capsules containing undisclosed sibutramine, phenolphthalein and frusemide is illegal.
JOYSMI 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 JOYSMI 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 of JOYSMI 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.
Report counterfeit medicines and medical devices
If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:
| Phone | 1800 020 653 |
|---|---|
| Online: | Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products |
| info@tga.gov.au |
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