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Australia Bans Obesity Drug Sibutramine

by Gopalan on  October 10, 2010 at 8:04 AM Drug News   - G J E 4
Australia has banned obesity drug sibutramine after a study showed it could cause a fatal heart attack or stroke. It has already been withdrawn from the US market.
 Australia Bans Obesity Drug Sibutramine
Australia Bans Obesity Drug Sibutramine
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Pharmaceutical company Abbott announced it would stop distributing the drug sold under the brand name Reductil in Australia since 2001, following a ruling by the Therapeutic Goods Administration.

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Abbott Australia spokeswoman Jennifer Stevenson said yesterday those using the prescription medicine should make an appointment with their doctor for advice on an alternative.

"Doctors should not issue any new prescriptions for sibutramine," she said. "Patients who wish to stop treatment before seeing their doctor can do so at any time."

The drug ban follows the release of data from the six-year and 10,000-patient SCOUT (Sibutramine Cardiovascular Outcome Trial), which showed the weight loss drug was tied to 16 per cent more major cardiovascular side-effects. The trial included 790 Australians.

Concerns about the drug are not new. It was always known the drug could affect blood pressure and heart rate, but it was believed this would be offset by weight loss.

But after preliminary results of the SCOUT study last November, the European Medicines Agency suspended the marketing of the drug while the TGA moved in June to tighten the conditions under which it could be prescribed.

The TGA carried out its own review and consulted the US Food and Drug Administration before deciding to ban the drug on Friday, TGA spokeswoman Kay McNiece said.

"Analysis of the final results of the SCOUT study have since confirmed there is an increase in risk of major cardiac events such as heart attack and stroke in obese and overweight patients taking sibutramine," she said.

Abbott estimates 30 million people have used sibutramine worldwide since 1997. Ms Stevenson would not say how many people had used the drug in Australia since 2001, although it was a "modest-sized product for Abbott in Australia".

Patients who have recently bought the drug will be able to return their current supply to their pharmacy for a refund, she said.

The drug had the supposed effect of making people feel fuller, helping to burn calories faster. It was expensive - $80 for a 30-day supply - and its benefits were questionable, doctors say.

Australian Medical Association vice-president Steven Hambleton said the SCOUT study showed the weight loss benefits of Reductil were only 2.5 per cent more than a placebo, a "disappointing" result.

"Drugs, in the main, have a disappointing outcome. In the end, it's about ELF - Eat Less Food."

Global sales of sibutramine in the first nine months of this year were $US80 million ($81.2 million).

Meantime in Hong Kong the Department of Health (DH) has also received notification from Abbott that the company would voluntarily withdraw the registration of Reductil and its generic version Sibutil (both containing sibutramine) and recall the products from local shelves.

Source: Medindia
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