PURPOSE: Examine use, patient awareness and outcomes of concurrent cerivastatin and gemfibrozil in a public hospital clinic system 2 weeks following cerivastatin withdrawal. METHODS: Electronic pharmacy records for cerivastatin prescriptions for 1 year preceding withdrawal were downloaded and linked to gemfibrozil prescriptions. Patients with concurrent prescriptions were surveyed for current use, awareness of withdrawal/warnings, adverse effects and creatine phosphokinase (CK) results. RESULTS: From August 2000 to August 2001, 29,377 prescriptions for cerivastatin were dispensed for 10,780 unique patients; 211 (2%) also received gemfibrozil. Prescription time frames for the two drugs overlapped for 67 patients. Interview of 47 patients revealed 35 actually taking both. 18/35 (51.4%) were still taking both drugs 2 weeks after market-withdrawal of cerivastatin. Only 7/46 (21.2%) had 'heard the news' about withdrawal. 19/46 (41.3%) described muscle-related symptoms; nine reported severe symptoms. Only 13 (28.3%) had CK monitoring. 5/8 symptomatic patients monitored had CK values > 200 U/L. (> 1000 U/L in two cases.) CONCLUSIONS: Despite escalating labeled warnings, nearly 2% of patients prescribed cerivastatin received gemfibrozil prescriptions, 1/3 concurrently. Most were still taking this combination 2 weeks after cerivastatin withdrawal and unaware of publicized warnings. Nearly half experienced muscle-related symptoms. More reliable methods for preventing prescription/dispensing of interacting medications and alerting patients about drug recalls are warranted.
PURPOSE: Examine use, patient awareness and outcomes of concurrent cerivastatin and gemfibrozil in a public hospital clinic system 2 weeks following cerivastatin withdrawal. METHODS: Electronic pharmacy records for cerivastatin prescriptions for 1 year preceding withdrawal were downloaded and linked to gemfibrozil prescriptions. Patients with concurrent prescriptions were surveyed for current use, awareness of withdrawal/warnings, adverse effects and creatine phosphokinase (CK) results. RESULTS: From August 2000 to August 2001, 29,377 prescriptions for cerivastatin were dispensed for 10,780 unique patients; 211 (2%) also received gemfibrozil. Prescription time frames for the two drugs overlapped for 67 patients. Interview of 47 patients revealed 35 actually taking both. 18/35 (51.4%) were still taking both drugs 2 weeks after market-withdrawal of cerivastatin. Only 7/46 (21.2%) had 'heard the news' about withdrawal. 19/46 (41.3%) described muscle-related symptoms; nine reported severe symptoms. Only 13 (28.3%) had CK monitoring. 5/8 symptomatic patients monitored had CK values > 200 U/L. (> 1000 U/L in two cases.) CONCLUSIONS: Despite escalating labeled warnings, nearly 2% of patients prescribed cerivastatin received gemfibrozil prescriptions, 1/3 concurrently. Most were still taking this combination 2 weeks after cerivastatin withdrawal and unaware of publicized warnings. Nearly half experienced muscle-related symptoms. More reliable methods for preventing prescription/dispensing of interacting medications and alerting patients about drug recalls are warranted.
Authors: Aukje K Mantel-Teeuwisse; Olaf H Klungel; Toine C G Egberts; W M Monique Verschuren; Arijan J Porsius; Anthonius de Boer Journal: Drug Saf Date: 2004 Impact factor: 5.606
Authors: Peter J Embi; Prasad Acharya; Mark McCuistion; Charles P Kishman; Doris Haag; Stephen Marine Journal: J Med Internet Res Date: 2006-09-06 Impact factor: 5.428