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Registration status of sibutramine

posted Feb 22, 2010, 6:49 AM by 藥物教育資源中心DERC

For SHPHK members' information, the president has received a letter from Pharmaceutical Service, Department of Health which clarifies the current view of the Registration Committee of the Pharmacy of Poisons Board regarding sibutramine. Pertinent quotes from the letter follow:

The Registration Committee of the Pharmacy and Poisons Board has reviewed the available data on the safety of subutramine. In view of the fact that the final results of a large study on the safety of the drug, known as the Sibutramine Cardiovascular Outcome Trail or SCOUT, are yet to be published, the Committee has decided that this drug should continue to be available until more data is available for a comprehensive appraisal of the safety of the drug. In reaching this decision, the Committee has also taken note that the recommendation of the Committee for Medicinal Products for Human Use of the European Medicines Agency to suspend the registration of medicines containing sibutramine in the European Union is yet to be adopted by the EU, and that the Food and Drug Administration of the United States, the Therapeutic Goods Administration of Australia and the Health Sciences Authority of Singapore have decided to allow sibutramine to remain available.

The Committee continues to monitoring the situation and will let you know if any regulatory action will be taken.

As mentioned in my previous letter, medicines containing sibutramine should not be used in patients with a history of coronary heart disease, congestive heart failure, arrhythmias or stroke. Your members are therefore reminded to exercise extra caution when dispensing this drug to your clients.