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Fact
sheet

Friday 22 October 2010

Product recall due to presence of sibutramine

Three brands of imported coffee and chocolate have been recalled from sale
after they were found to contain sibutramine, a prescription medication not
permitted in foods.

The recalled products are:

Moti Angel Coffee

Sumabe Acai Berry Coffee

Leptin weight loss chocolate

They are marketed and labelled as ‘slimming foods’ and could lead to a higher
risk of cardiovascular disease in people who are overweight or obese.

Sibutramine has been withdrawn from sale in Australia due to concens
regarding the safety of the drug. It was found that there were higher rates of
cardiovascular events such as heart attack or strokes in overweight patients
using sibutramine. Sibutramine can also interact with many commonly prescribed
medications.

Due to concerns of a risk to public health, the importers of these products
are undertaking a recall.

NSW Chief Health Officer, Dr Kerry Chant has urged consumers considering
using weight loss products to discuss a weight control plan with their general
practitioner.

“Sale of weight loss supplements, including herbal remedies, which include
this undeclared drug ingredient is also known to occur overseas,” Dr Chant
said.

“The NSW Food Authority is testing a range of similar products and will alert
consumers if any further health risks become known. Consult your GP if you would
like any further advice regarding weight loss alternatives,” Dr Chant added.

Consumers who have purchased the product are advised to return it to the
place of purchase or dispose of the product.

Fact sheet: Possible health effects from the consumption of weight loss
products containing sibutramine

22    October 2010

Food and Health Authorities are undertaking a recall of Sumabe Acai Berry
Coffee, Moti Angel Coffee and Leptin Weight Loss Chocolate. The products were
found to contain the therapeutic substance, sibutramine The products were not
labelled as containing sibutramine or other therapeutic substances.

These products were found to contain sibutramine at levels which would reach
the therapeutic dose if ingested at the recommended daily dose and could lead to
adverse effects.   Using more than the suggested amount could lead to
extensive side effects.

Sibutramine was withdrawn from the market in Australia on 9 October 2010
after the analysis of results from a major health study known as the Sibutramine
Cardiovascular OUTcomes (SCOUT) study.

There was found to be higher rate of cardiovascular events (such as heart
attack and stroke) in obese and overweight patients using sibutramine than in
patients managing their weight through exercise and diet alone. Sibutramine may
also cause increased heart rate, palpitations, raised blood pressure, nausea,
constipation, insomnia, dizziness, paraesthesia, sweating, headache, anxiety.
Sibutramine interacts with many commonly prescribed medications

Doctors should be alert to seek information about the use of weight loss
products in any person presenting with unexplained cardiovascular symptoms.

Consumers should cease consumption immediately and return product to point of
sale or dispose of safely out of the reach of children. Consumers should seek
medical advice if concerned about their previous consumption of these
products.

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