The US Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) program in practice: does it really inform patients and limit risk?

MeSH terms

• Chronic Disease
• Epoetin Alfa
• Erythropoietin / adverse effects*
• Heart Failure / epidemiology
• Hematinics / adverse effects
• Humans
• Kidney Diseases / therapy*
• Patient Education as Topic / methods*
• Physician-Patient Relations*
• Recombinant Proteins / adverse effects
• Renal Dialysis
• Risk Assessment / methods*
• Risk Factors
• Risk Management*
• Stroke / epidemiology
• United States
• United States Food and Drug Administration*