有用資料
Letter to Doctors
Fenfluramine Reminder
22 August 2002
Dear Doctor,
I write to bring to your attention to a slimming product which contains a banned drug, fenfluramine.
On August 22, 2002, the Government Laboratory confirmed the presence of fenfluramine in a product under the name of "Seven Days Seven Fairy Maidens Forever - Youth Immunity Capsule" (七仙七日常駐青免疫膠囊). Investigation by the Department of Health found that the product was once available in Hong Kong.
Fenfluramine has been linked to the development of valvular heart diseases, especially aortic insufficiency and mitral insufficiency. The use of fenfluramine, particularly for four months or longer, is associated with an increased risk of cardiac valve disorders, particularly aortic regurgitation (N Engl J Med 1998; 339:719-724). Progression of valvular abnormalities is unlikely to occur in patients 13-26 months after discontinuation of fenfluramine (JAMA 2001; 286:2011-2014).
With effect from January 1, 1998, pharmaceutical products containing fenfluramine have been deregistered in Hong Kong.
The United States Department of Health and Human Services has issued the following public health recommendations regarding fenfluramine (MMWR, November 14, 1997, 46(45);1061-1066):
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All persons exposed to fenfluramine or dexfenfluramine, for any period of time, either alone or in combination with other agents, should undergo a medical history and cardiovascular examination by their physician to determine the presence or absence of cardiopulmonary signs or symptoms.
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An echocardiographic evaluation be performed on all persons who were exposed to fenfluramine or dexfenfluramine for any period of time, either alone or in combination with other agents, and who exhibit cardiopulmonary signs (including a new murmur) or symptoms suggestive of valvular disease (e.g., dyspnea).
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Although the clinical importance of asymptomatic valvular regurgitation in exposed patients and the risk for developing bacterial endocarditis in these patients are unknown, practitioners should strongly consider performing echocardiography on all persons -- regardless of whether they have cardiopulmonary signs or symptoms -- who have been exposed to fenfluramine or dexfenfluramine for any period of time, either alone or in combination with other agents, BEFORE the patient undergoes any invasive procedure for which antimicrobial endocarditis prophylaxis is recommended by 1997 American Heart Association (AHA) guidelines. Any echocardiographic findings that meet the AHA criteria for prophylaxis -- regardless of whether they are attributable to possible fenfluramine or dexfenfluramine use -- should be recognized as indications for antibiotic prophylaxis. The invasive procedures include certain medical or dental procedures where antibiotic prophylaxis is recommended as defined by the 1997 AHA guidelines. For emergency procedures for which cardiac evaluation cannot be performed, empiric antibiotic prophylaxis should be administered according to the 1997 AHA guidelines.
All health care professionals are advised, in the management of patients who have taken preparations containing fenfluramine, to bear in mind the possible risk of bacterial endocarditis for patients with valvular disease. Doctors who come across patients with cardiac valvular lesions, or any other adverse reactions, who have been exposed to fenfluramine or dexfenfluramine, either alone or with another drug or drugs, should report these to the Chief Pharmacist of the Department of Health at:
Pharmaceutical Service,
3/F Public Health Laboratory Centre,
Nam Cheong Street, Kowloon
Fax No: 2834 5117
Tel No: 2572 2068
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Yours faithfully,
(Dr Cindy Lai) for Director of Health |
