zelnorm

 

 

 

 

 

 

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圖片轉自諾華網頁:http://www.novartis.com.tr/pharma/01_html/ZElmac.asp

 

小藥師註:tegaserod為5HT-4的agonist,與Cisapride類似藥理機轉

諾華聲明稿:

On March 30, Novartis announced that it is complying with an FDA request to suspend marketing of Zelnorm.

A recent analysis of clinical trial data identified a small imbalance that was statistically significant in the number of cardiovascular ischemic events in patients taking Zelnorm. These events included heart attack, stroke and unstable angina. They occurred primarily in patients who had pre-existing cardiovascular disease and/or cardiovascular risk factors. There is no demonstrated causal relationship between Zelnorm and these events.

Patients who are taking Zelnorm should speak with their doctor about other appropriate treatment options. Patients can return any unused and unexpired Zelnorm tablets to Novartis for reimbursement of out-of-pocket costs. More information can be obtained by calling the Novartis Customer Interaction Center at 888-NOW-NOVA (888-669-6682).

Novartis believes that Zelnorm provides important benefits for appropriate patients with irritable bowel syndrome with constipation. We will discuss with the FDA the best way to continue to make this medication available to patients.

衛生署宣布,女性便秘型大腸躁鬱症短期治療用藥「暢能錠」,會增加心臟病風險,美國食品藥物管理局(FDA)已要求藥廠停止販售,台灣也跟進,要求藥廠在今年六月卅日前下市。

衛生署藥政處長廖繼洲說,FDA根據新出爐的一分研究分析,研究涵蓋11614名使用暢能錠患者,及7031名使用安慰劑的對照組患者,結果發現,使用暢能錠的患者中,有13人出現嚴重或危及生命的心血管不良反應,包括三人中風、六人嚴重胸痛、四人心臟病發(其中一人死亡);對照組僅一人出現心血管不良反應。

衛生署藥物不良反應通報中心前年底接獲一例通報,一名71歲女性中風,懷疑與此藥有關。暢能錠商品名為Zelmac,為諾華公司生產,衛生署昨天宣布將廢止藥證,並要求藥廠回收下市。

廖繼洲說,此藥健保不給付,使用暢能錠的患者,應儘速與醫師聯絡,改用其他藥物代替。書田診所大腸直腸科主治醫師胡煒明說,暢能在臨床上較少使用,如有便秘,建議患者多攝取蔬菜、水果,多喝水及運動,這些方法還無法改善,才會考慮開纖維素給患者服用。

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