有用资料
29 October 2004
Dear Doctors,
Recall of "Vioxx"
I refer to the recent world-wide recall of the drug "Vioxx" (rofecoxib) by the manufacturer Merck, Sharp and Dohme (MSD).
The recall was initiated by MSD. The basis of the recall is the company's concern about the possible increase of risk of cardiovascular events (heart attacks and stroke) in patients on long-term use of the drug. MSD has embarked on a 3-year clinical trial aimed at studying the use of Vioxx 25mg daily for a new indication, i.e. the prevention of recurrence of colorectal polyps in patients with a history of colorectal adenomas. Statistical analysis of trial data has found that there is an increase in the relative risk for heart attacks and stroke in patients after taking the trial drug for 18 months continuously compared with those patients on placebo.
Vioxx was approved in Hong Kong in 1999. The approved uses of the drug are the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis, management of acute pain and treatment of primary dysmenorrhoea. The cardiovascular risks of the drug have already been known. However, the risks associated with the use of the drug as per the approved instruction are considered to be small. The Department of Health has not received any reports of cardiovascular events.
The Department of Health has been informed of the recall by MSD and has been following closely the recall exercise. The Department notes that the company issued a press statement announcing the recall on September 30 and has alerted all doctors, hospitals and dispensaries to whom it has supplied the drug. You are urged to return the drug to the supplier if you have not already done so.
You are advised to take note of the recall exercise which is a voluntary decision of the manufacturer, and to prescribe other suitable forms of medication.
MSD has set up a telephone hotline (2835 9819) to handle any enquiries which you, or any member of the public might have on the drug and the recall exercise.
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Yours sincerely,
(A.W.K. Chan) |