High rates of adverse effects and patient unawareness of withdrawn lipid-lowering drug combination in a public hospital clinic.
OBJECTIVE
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.
Schiff
Gordon D
GD
Departments of Medicine and Pharmacy, Cook County Hospital, 1900 W. Polk Street, Room 901, Chicago, IL 60612, USA. gdschiff@aol.com
Keehr
Leah M
LM
Sai
Theophilus T
TT
Bult
Judilynn
J
D003402:Creatine Kinase / Q000187:drug effects; D004347:Drug Interactions / Q000502:physiology; D015248:Gemfibrozil / Q000009:adverse effects*; D006779:Hospitals, Public; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects*; D000960:Hypolipidemic Agents / Q000009:adverse effects*; D018908:Muscle Weakness / Q000139:chemically induced*; D010146:Pain / Q000209:etiology*; D010353:Patient Education as Topic; D011725:Pyridines / Q000009:adverse effects*
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000960:Hypolipidemic Agents; D011725:Pyridines; C086276:cerivastatin; D003402:Creatine Kinase; D015248:Gemfibrozil