cerivastatin and Muscle-Weakness

Topics: Drug Industry; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Muscle Weakness; Pyridines; Renal Insufficiency

The authors describe a patient who presented with myoglobinuria after starting cerivastatin-gemfibrozil therapy. Muscle histochemistry revealed ragged-red fibers and cytochrome c oxidase negative (COX) fibers, and biochemistry showed a defect of COX activity. Immunoblot analysis showed a 60% reduction of COX I and COX II polypeptides. Cerivastatin myotoxicity might be related to a depletion of essential metabolites needed to anchor COX subunit I to mitochondrial membrane.

Topics: Aged; Biopsy; Cytochrome-c Oxidase Deficiency; Female; Gemfibrozil; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypolipidemic Agents; Muscle Fibers, Fast-Twitch; Muscle Weakness; Muscle, Skeletal; Myoglobinuria; Pain; Pyridines

Statins are now widely prescribed and without doubt save many lives. However there are rare potentially serious side-effects, including acute renal failure. Patient education and physician vigilence are vital.

Topics: Acute Disease; Aged; Humans; Male; Muscle Weakness; Pyridines; Renal Insufficiency; Rhabdomyolysis

Examine use, patient awareness and outcomes of concurrent cerivastatin and gemfibrozil in a public hospital clinic system 2 weeks following cerivastatin withdrawal.. 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.. 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.). 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.

Topics: Creatine Kinase; Drug Interactions; Gemfibrozil; Hospitals, Public; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypolipidemic Agents; Muscle Weakness; Pain; Patient Education as Topic; Pyridines

Topics: Cholesterol, LDL; Drug and Narcotic Control; Drug Interactions; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Liver; Muscle Weakness; Product Surveillance, Postmarketing; Pyridines; Rhabdomyolysis; Risk Factors

Topics: Anticholesteremic Agents; Anuria; Clopidogrel; Coronary Artery Bypass; Humans; Hypercholesterolemia; Intracranial Thrombosis; Male; Middle Aged; Muscle Weakness; Myocardial Infarction; Platelet Aggregation Inhibitors; Postoperative Complications; Pyridines; Rhabdomyolysis; Ticlopidine