Related Experiment Videos
The cerivastatin withdrawal crisis: a "post-mortem" analysis
Marina Maggini1, Roberto Raschetti, Giuseppe Traversa
1National Center of Epidemiology, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Roma, Italy. mmaggini@iss.it
Abstract:
In August 2001, cerivastatin was removed from European and USA markets because of a higher risk of rhabdomyolysis associated with its use in comparison with other statins. The objective of this study was to compare cholesterol-lowering drug use in Italy before and after the withdrawal of cerivastatin from the market, and to evaluate if the withdrawal influenced patients compliance and physicians prescribing habits. After August 2001, 48% of cerivastatin users discontinued any statin treatment. The major risk factor for discontinuation was a concomitant use of fibrate during the first 7 months of 2001 (OR = 2.3; 95% CI = -2.9). Comparing the discontinuation of statin therapy between 2001 and 2000 we can estimate that there was a 5% increase, corresponding to about 200,000 patients, who discontinued statin therapy during autumn 2001 because of cerivastatin emergency.
Related Concept Videos
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Drug Toxicity: Risk factors
Therapeutic Drug Monitoring: Affecting Factors
Pharmaceutical Poisoning: Potential Scenarios
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
Acute Coronary Syndrome III: Diagnostic Studies