「藥物安全簡訊」出刊計畫

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1 ~~~~~~~~~~~~~~~~~~~~~~~~~~ Drug Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ Fenoverine 玲 麗 不良 Fenoverine Spasmopriv; Morfin; Fenorine phenothiazine 類 non-anticholinergic 滑 來 療 泌尿 1, 2 療 離 流 3-5 流刺 4 滑 synchronize 3,4 尿路 狀 量 粒 100 量 Fenoverine 臨 狀 例 便 1,2 數 rhabdomyolysis 例 rhabdomyolysis 6,7 myoglobin creatine kinase CK lactate dehydrogenase LDH glutamic oxaloacetic transaminase GOT 臨 狀 myalgia 尿 myoglobinuria 不 CK 療 CK total serum CK 6 療 療 不 利尿 行 6-8 若 療 復 Drug Safety Newsletter 2004 Sept. Vol.7 1

2 類 理 車 力 烈 見 年來 精 兩 1 離 sarcoplasmic reticulum sodium-potassium ATPase 易 都 見 例 識 見 類 降 fibric acid derivatives clofibrate, gemfibrozil HMG-Co A reductase inhibitors lovastatin, simivastatin, pravastatin niacin 2. 精神 antipsychotic agents neuroleptic malignant syndrome 神 數 狀 3. antidepressive agents serotonin syndrome 臨 神 狀 4. 例 barbiturates 5. 精神 例 精 洛 phencyclidine 6. 類 不 易 了 例 精 若 Drug Safety Newsletter 2004 Sept. Vol.7 2

3 ~~~~~~~~~~~~~~~~~~~~~~~~~~ Drug Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ Fenoverine-related rhabdomyolysis Fenoverine 來 年 不良 68 兩例 fenoverine 率 療 數 例 10 老年 年 62 fenoverine 療 11 狀 fenoverine 療 Fenoverine rhabdomyolysis 不良 例 陸 1992 年 例 rhabdomyolysis 數 率 fenoverine fenoverine 11,15 Jouglard 6 15 臨 fenoverine 量 狀 療 1 12 不 狀 茶 尿 不 不 mitochondrial myopathy lipid storage myopathy sensitivity to malignant hyperthermia disorder of oxidative metabolism fenoverine fenoverine 便 fenoverine 臨 狀 說 fenoverine 隸 phenothiazine 類 不論 說 fenoverine rhabdomyolysis Chariot 兩 fenoverine rhabdomyolysis 行臨 理 10 兩 年 都 60 fenoverine 療 量 fenoverine 3 4 力 狀 來都 了 left bundle branch block 論 Drug Safety Newsletter 2004 Sept. Vol.7 3

4 fenoverine 度 降 ciprofibrate 狀 2 兩 CK 便 復 臨 狀 度 狀 5 來 fenoverine 10 兩 3-6 切 理 都 fenoverine 落 數 論 fenoverine rhabdomyolysis 兩 降 fenoverine 臨 狀 便 立 惡 料 1991 年 欄 列 rhabdomyolysis 欄 說 若 不 fenoverine CK 1995 年 fenoverine 利 15 Fenoverine 數 不 倫 度 年 2000 年 年 不良 料 若 量 300 療 6 來 年 634,527 fenoverine 療 rhabdomyolysis 例 4 fenoverine-induced rhabdomyolysis 率 療 6.3 例 例 來 不良 料 六 例 不良 Drug Safety Newsletter 2004 Sept. Vol.7 4

5 ~~~~~~~~~~~~~~~~~~~~~~~~~~ Drug Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ 料 年 4 fenoverine rhabdomyolysis 例 度 料 年 了六 fenoverine 100 若 3 療 3 6 來 年 fenoverine 療 fenoverine-induced rhabdomyolysis 率 量 數 數 率 更 rhabdomyolysis fenoverine rhabdomyolysis 老年 年 都 / 例 fenoverine 量 理 療 量 論 類 fenoverine 率 累 了 度 rhabdomyolysis 率 10,17 例 77 C fenoverine 療 療 6 狀 更 立 類 EM voren rhabdomyolysis fenoverine fenoverine 療 9 尿量 狀 CK creatinine 數 療 16 fenoverine 了 類 論 fenoverine 不良 料 行 fenoverine Drug Safety Newsletter 2004 Sept. Vol.7 5

6 fenoverine-induced rhabdomyolysis 臨 行 立 論 理 略 行 論 1 fenoverine rhadbomyolysis 9-17 不良 料 不良 料 料 都 fenoverine-induced rhabdomyolysis 行率 rhabdomyolysis 率 來便 率 論? 2 Fenoverine-induced rhabdomyolysis 率 療 數 率 數 更 率不 例 3 臨 理 量 流行 療行 fenoverine-induced rhabdomyolysis 老年 rhabdomyolysis 例 精 降 行 fenoverine 率 不易 立 數 臨 略 漏 類 臨 行 fenoverine fenoverine 不良 B C Drug Safety Newsletter 2004 Sept. Vol.7 6

7 ~~~~~~~~~~~~~~~~~~~~~~~~~~ Drug Safety Newsletter~~~~~~~~~~~~~~~~~~~~~~~~~ 率 益 fenoverine fenoverine 益 不利 來 不 fenoverine 臨 說 參 料 1. Bader F. Fenoverine: a two-step, double-blind and open clinical assessments of its smooth muscle synchronizing effects. Pharmatherapeutica 1986; 4(7): Camarri E. Fenoverine: smooth muscle synchronizer for the management of gastro-intestinal conditions. II. A trimebutine-controlled, double-blind, crossover clinical evaluation. Curr Med Res Opin 1986; 10(1): De Santis D, Marrazzo R, Losasso C, et al. Pharmacodynamic profile of fenoverine, a novel modulator of smooth muscle motility. Drugs Exp Clin Res 1989; 15(1): Gonella J, Lalanne C, Mironneau J. Fenoverine: a novel synchronizer of smooth muscle motility by interference with cellular calcium flow. Curr Med Res Opin 1987; 10(7): Mironneau J, Arnaudeau S, Mironneau C. Fenoverine inhibition of calcium channel currents in single smooth muscle cells from rat portal vein and myometrium. Br J Pharmacol 1991; 104(1): Coco TJ, Klasner AE. Drug-induced rhabdomyolysis. Curr Opin Pediatr 2004; 16(2): Vanholder R, Sever MS, Erek E, Lameire N. Rhabdomyolysis. J Am Soc Nephrol 2000; 11(8): Prendergast BD, George CF. Drug-induced rhabdomyolysis--mechanisms and management. Postgrad Med J 1993; 69(811): Benamouzig R, Chaussade S, Roche H, et al. [Acute rhabdomyolysis and necrotizing enterocolitis after ingestion of fenoverine]. Gastroenterol Clin Biol 1992; 16(8-9): Chariot P, Ratiney R, Le Maguet F, Fourestie V, Astier A, Gherardi R. Fenoverine-induced rhabdomyolysis. Hum Exp Toxicol 1995; 14(8): Chichmanian RM, Fuzibet JG, Mignot G, Dujardin P. [Acute rhabdomyolysis induced by fenoverine. 2 cases]. Ann Med Interne (Paris) 1990; 141(5): Dutertre JP, Asselin F, Jonville AP, Benhamou C, Autret E. [Rhabdomyolysis with acute renal insufficiency caused by fenoverine]. Ann Med Interne (Paris) 1991; 142(7): Hardin JM, Guillebaud JC, Lallement PY, Matta B, Andrejak M. [Rhabdomyolysis associated to fenoverin therapy and complicated by acute renal failure]. Therapie 1992; 47(2): Hebuterne X, Chichmanian RM, Cohen HL, Rampal P. [Acute rhabdomyolysis due to fenoverine]. Gastroenterol Clin Biol 1991; 15(11): Jouglard J, Kozak-Ribbens G, de Haro L, Cozzone PJ. Research into individual predisposition to develop acute rhabdomyolysis attributed to fenoverine. Hum Exp Toxicol 1996; 15(10): Ouakil H, Pouchot J, Debin ML, Le Bourdelles G, Coste F, Vinceneux P. [Acute rhabdomyolysis caused by fenoverine]. Rev Med Interne 1994; 15(10): Drug Safety Newsletter 2004 Sept. Vol.7 7

8 17. Sultan S, Lesgourgues B, el Attar Y, Fauvelle F, Delas N. [Acute rhabdomyolysis due to fenoverine (Spasmopriv). A case and review of the literature]. Therapie 1992; 47(5): 443. Drug Safety Newsletter 2004 Sept. Vol.7 8