Post-Marketing Surveillance of Amrinone (Amcoral Injection 50 100): Special Investigation of Background Risk Factors for Amrinone-Mediated Thrombocytopenia:Special Investigation of Background Risk Factors for Amrinone-Mediated Thrombocytopenia

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A prospective post-marketing surveillance study of amrinone (Amcoral® injection 50 and 100) was carried out for one year from April 2000 until March 2001 in patients with acute cardiac failure (including acute exacerbation of chronic cardiac failure) inadequately controlled with other drugs in the field of internal medicine in order to identify the influence of the drug on platelet count. The results were as follows: 1. One hundred and ninety-nine cases (safety evaluable population: 198 ; efficacy evaluable population: 191) collected from 37 medical institutions were evaluated. 2. Efficacy rate in overall improvement rating was 72.1%, which was higher than that reported in the reexamination (65.9%). 3. Adverse drug reactions were reported in 32 (16.2%) patients. Of these, 18 (9.1%) patients had thrombocytopenia. 4. Fourteen of 18 patients with thrombocytopenia were elderly patients (≥75 years), indicating that this adverse drug reaction occurs more frequently in elderly patients and patients treated with drugs against cardiac failure just before the start of treatment with amrinone. 5. The majority of patients who had thrombocytopenia after treatment with amrinone exhibited increased CRP, a parameter of inflammation, suggesting that CRP is likely to be a predictor of the development of thrombocytopenia. 6. The other adverse drug reactions observed were decreased blood pressure (6 patients, 3.0%), arrhythmia (6 patients, 3.0%), anemia (2 patients, 1.0%), and aggravated hepatic function (1 patient, 0.5%).
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Post-Marketing Surveillance of Amrinone (Amcoral Injection 50 100): Special Investigation of Background Risk Factors for Amrinone-Mediated Thrombocytopenia:Special Investigation of Background Risk Factors for Amrinone-Mediated Thrombocytopenia

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