MSD 回收 Tredaptive (Extended Release Niacin/Laropiprant)

藥物副作用嚴重 全球回收「可穩醇」 01 - 22 00:03 (綜合報道)(星島日報報道)美國默沙東藥廠在全球回收治療血脂異常藥物「可穩醇」（Tredaptive）1g/20mg藥丸（二十八粒裝），因該藥物未能有效減少心臟病發和中風風險，卻令病人出現嚴重副作用包括出血、肌肉乏力、出現感染和新發糖尿病。有藥劑師估計本港約千名病人受影響。 醫院藥劑師學會會長崔俊明表示，「可穩醇」聲稱可降低壞膽固醇，以及增加好膽固醇的數量，從而預防心臟病發和中風；藥物於香港註冊編號為HK-57317。 歐洲藥品管理局上周五確定「可穩醇」停售的建議，因病人服用「可穩醇」對減少主要的血管問題如心臟病發和中風，未見顯著效益，但出現屬嚴重但非致命副作用的頻密程度卻增加，包括出血、肌肉乏力、出現感染和新發糖尿病。 據藥廠資料，去年約有一萬三千三百盒二十八粒裝的「可穩醇」藥物供應予本港藥房、醫生及醫院。崔俊明估計，每年約有千名病人使用該藥物，其中公立醫院中僅廣華醫院和瑪麗醫院以藥辦形式試用。他又指，如不向病人處方「可穩醇」，可以增加他汀類藥物的劑量或處方更強效的他汀類藥物。

Total recall of Tredaptive (Extended Release Niacin/Laropiprant) 1g/20mg Tablet  Hong Kong (HKSAR) - The Department of Health (DH) today (January 21) endorsed the total recall of Tredaptive (ER Niacin/Laropiprant) 1g/20mg Tablet (registration no. HK-57317) (Tredaptive) from the market by licensed drug wholesaler Merck Sharp & Dohme (Asia) Ltd (MSD) because new data showed that the benefits of the product no longer outweigh the risks for patients. "On January 11, 2013, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) considered the risks involved in taking three branded products - Tredaptive, Pelzont and Trevaclyn - all containing niacin and laropiprant, are greater than their benefits, and recommended the suspension of their marketing authorisation," a DH spokesperson said. "The recommendation of PRAC was based on the results from a large, long-term study called HPS2-THRIVE, which concluded that treatment with Tredaptive together with statin therapy failed to show significant benefit on the reduction of major vascular events such as heart attack and stroke compared with statin therapy alone. In addition, there was an increased frequency of serious, but non-fatal, side effects in patients taking the medicine, such as bleeding, muscle weakness, infections and new-onset diabetes." In Hong Kong, only Tredaptive is registered and is a prescription medicine used for the treatment of dyslipidaemia (i.e. abnormally high blood levels of fats such as triglycerides and cholesterol). MSD announced a global suspension of the availability of Tredaptive on the same day. On January 18, 2013, the Committee for Medicinal Products for Human Use of the EMA confirmed the PRAC recommendation. Today, MSD decided on a total recall of Tredaptive from the market. So far, the DH has not received any adverse drug reaction reports related to the use of Tredaptive. According to MSD, about 22,300 packs (size 28) of Tredaptive were imported into Hong Kong in 2012. About 13,300 packs were supplied to pharmacies, doctors and hospitals. MSD has set up a hotline 3971 2913 to answer public enquiries. The DH will closely monitor the recall.Members of the public currently receiving Tredaptive should consult healthcare professionals to review their treatment plans. Source: HKSAR Government