Published: 1 August 2019
Safety Information
Alert Communication
Medsafe is issuing a warning to consumers to stop taking Go lean Detox and Go Detox – statement under section 98 of the Medicines Act 1981
1 August 2019
Go lean Detox and Go Detox have been found to be adulterated with sibutramine and phenolphthalein. These two substances are both prescription medicines. Sibutramine is known to cause serious adverse events relating to the heart and circulation, and phenolphthalein is known to have laxative effects.
Advice for consumers and caregivers
Information for healthcare professionals
Products affected
Further information
Useful links
Advice For consumers and caregivers
- Consumers who have purchased these products should stop taking them immediately.
- The products should be returned to the point of sale or safely disposed of.
- If you have suffered any adverse consequences following the use of these products you should go to your healthcare professional and advise them that you have been taking a product adulterated with sibutramine and phenolphthalein.
Information for healthcare professionals
- Go lean Detox and Go Detox have been sold for weight loss and contain the prescription medicines sibutramine (10mg) and phenolphthalein (30mg).
- Sibutramine containing medicines were removed from the market in 2010 because of the increased risk of heart attacks and strokes.
- Medsafe has been notified of one patient that has suffered an adverse event attributed to use of one of these products.
- The products are sold as herbal capsules for weight loss.
- If a patient presents with adverse events that may possibly be attributable to either sibutramine or phenolphthalein, then use of the above adulterated products should be considered.
- The product labels include a list of herbal ingredients, but the presence of sibutramine and phenolphthalein is not declared.
Products Affected
Go lean Detox
Go Detox
The products claim to enhance fat metabolism, help weight loss and reduce the risk of obesity.
The labelling declares that the product is a food, not a medicine, and should not be taken with other medicines.
Images of Go lean Detox and Go Detox products.
Further Information
In 2010 a ministerial advisory committee recommended that the consent to distribute the weight-loss medicine containing sibutramine be revoked after its review which confirmed that the risks outweighed the benefits of using this medicine. Sibutramine was found to raise the risk of heart attacks and strokes. Medicines containing sibutramine were also withdrawn from the Australian, Canadian, United States and European markets at that time.
Phenolphthalein has a known laxative effect and was marketed in medicines for constipation in the past. It is no longer available in medicines in New Zealand.
Medsafe was first alerted to this issue by the United States Food and Drug Administration (USFDA) through the international rapid alert system.
Other international regulators, including the Therapeutic Goods Administration (TGA) in Australia and the USFDA have published notices warning of these products.
Medsafe identified outlets in the lower North Island that were supplying these products. Testing by the Institute of Environmental Science and Research (ESR) confirmed that the products supplied in New Zealand were adulterated with sibutramine and phenolphthalein.
All located stock has been seized.
As it is possible that other individuals or businesses may have imported these products for sale, but not been identified by Medsafe, this warning is published to alert consumers of the dangers of these products.
Useful links
