July 2, 2010 —US Food and Drug Administration (FDA) 經過ADR收集而公布須注意13個藥物
有服用以下藥物者必須小心注意副作用的發生，因可能具有致死性。
- azithromycin (Zithromax; Pfizer)
- Ø 代謝：35 % 肝臟代謝，並且經膽汁排泄
- Ø 副作用：associated with liver failure。如：肝臟指數上升、肝炎、膽汁瘀滯性黃疸、hepatic necrosis。2 g ER劑型，甚至有可能引起幽門狹窄問題。
- Clarithromycin
- Ø 代謝：部分經由CYP3A4代謝。排除：Fecal: 4%; Renal: 20 to 40%
- Ø 副作用：(可逆性) cholestatic hepatitis, with or without jaundice
- prasugrel (Effient; Eli Lilly)：抗凝血劑
- Ø 機轉：irreversible inhibition of the platelet P2Y12 adenosine diphosphate (ADP) receptor
- Ø 副作用：須注意發生thrombotic thrombocytopenic purpura (週邊小血管發生血栓，具致死性)
近年有心臟科醫師提出，此藥似乎具有致癌性！因而具有爭議。
- dronedarone (Multaq; Sanofi-Aventis)：
- Ø 機轉：
- Ø 用於治療心房纖維顫動、心房撲動。對於具有新房纖維顫動的病人傾向於替代amiodarone的使用，效果較佳，安全性也較佳。但近幾年研究卻顯是有些病人卻出現CHF(congestive heart failure)的副作用。
- Ranolazine (Ranexa; Gilead)：用於治療心絞痛(angina)。近來ADR收集發現有出現torsades de pointes(心室跳動過快)的案例。因而需注意！
Potential Signals of Serious Risks/New Safety Information Identified by AERS, First Quarter 2010
|
Product Name: Active Ingredient (Brand Name) or Product Class |
Potential Signal of a Serious Risk/New Safety Information |
|
Azacitidine (Vidaza; Celgene) |
Acute febrile neutrophilic dermatosis (Sweet's syndrome) |
|
Azithromycin (Zithromax) |
Liver failure |
|
Azithromycin extended release 2 g (Zmax) |
Pyloric stenosis |
|
C1 esterase inhibitors (Cinryze; ViroPharma; Berinert; CSL Behring) |
Thromboembolic events in patients with certain thrombogenic risk factors |
|
Clarithromycin (Biaxin) |
Liver failure |
|
Daptomycin (Cubicin) |
Pulmonary eosinophilia, eosinophilic pneumonia |
|
Dronedarone hydrochloride (Multaq) |
Congestive heart failure |
|
Estrogens, conjugated (Premarin) |
Angioedema |
|
Modafinil (Provigil) |
Convulsion |
|
Prasugrel hydrochloride (Effient) |
Thrombotic thrombocytopenic purpura |
|
Ranolazine (Ranexa) |
Torsades de pointes |
|
Sodium oxybate (Xyrem) |
Convulsion |
|
Temsirolimus (Torisel; Pfizer) |
Infusion site extravasation |
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