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The Department of Health (DH) today (October 8) received notification from licensed drug company Abbott Lab Ltd that the company would voluntarily withdraw the registration of Reductil and its generic version Sibutil (both containing sibutramine) in Hong Kong and recall the products from local shelves.
Products containing sibutramine are prescription medicines indicated for weight loss. Its side effects include increased blood pressure and heart rate, psychosis and possibly convulsion. It should not be taken by people with heart problems.
Reductil is registered with two strengths, Reductil 10 mg Cap (HK-45883) and Reductil 15 mg Cap (HK-45885) while Sibutil is registered as Sibutil 10 mg Cap (HK-55950) and Sibutil 15 mg Cap (HK-55949).
Marketing of sibutramine in Europe has already been suspended by the European Medicines Agency.
The regulatory action followed an analysis of the available results of a major study known as the Sibutramine Cardiovascular OUTcomes (SCOUT) study, which showed a 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.
DH issued letters to inform healthcare professionals early this year about the issue. The package inserts had already carried a warning that the medicine should not be used by patients with history of cardiovascular events.
As informed by Abbott Lab Ltd, the company will also cease supply of Reductil in Australia.
There are 49 other generic products containing sibutramine registered in Hong Kong.
The Registration Committee of the Pharmacy and Poisons Board will discuss the updated results of the SCOUT study in the coming meeting.
A hotline (8228 3118) has been set up by the company for public enquiries.
A spokesman for DH said any patients currently taking sibutramine who have concerns should approach healthcare professionals for advice.
Ends/Friday, October 8, 2010
Issued at HKT 21:22
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