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De-registration of pharmaceutical products containing sibutramine

     The Department of Health (DH) today (November 2) drew public attention to the de-registration of pharmaceutical products containing sibutramine as recommended by the Registration Committee of the Pharmacy and Poisons Board.

     The Committee's decision was made at its meeting today, having taken into consideration findings from the Sibutramine Cardiovascular Outcomes (SCOUT) study, the use of the product in Hong Kong, and regulatory actions in other international regulatory agencies.

     The SCOUT study 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.

     Furthermore, the study did not clearly show that the modest weight loss was maintained when sibutramine treatment had stopped.

     Based on these findings and the overall assessment, the Committee concluded that the increased cardiovascular risk of sibutramine outweighed the modest weight loss seen in patients, and consequently that pharmaceutical products containing sibutramine should be de-registered.

     In Hong Kong, Abbott Lab Ltd withdrew the registration of four products containing sibutramine and initiated a recall of the products from local shelves in October this year, following similar action by its counterparts in the US.

     Currently, there are still 45 sibutramine-containing products registered by 20 companies in Hong Kong. Internationally, sibutramine had been suspended or withdrawn from use in countries including Canada, China, the European Union, Singapore and the United States.

     A DH spokesman said: "The wholesalers concerned should immediately stop selling or distributing sibutramine-containing products and recall them from the market."

     "Doctors and pharmacies should stop prescribing or dispensing sibutramine-containing products and return their stocks to the respective wholesalers.

     "The wholesalers concerned have set up hotlines for public enquiries and the contact list is in Annex."

     Under the Pharmacy and Poisons Regulations, any person who sells, offers for sale or distributes or possesses for the purposes of sale, distribution or other use any deregistered pharmaceutical products is liable to prosecution.

     The spokesman said: "Patients who are taking sibutramine-containing products are advised to consult their doctors to discuss alternative measures to lose weight."

     "Weight control should be achieved through proper diet and appropriate exercise. Members of the public should consult healthcare professionals before using any medication for weight control."

     DH will closely monitor the recall of sibutramine-containing products by wholesalers.

Ends/Tuesday, November 2, 2010
Issued at HKT 20:24


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