title: How to evaluate the benefit-risk profile of newly marketed drugs.
authors.forename: L
authors.initials: L
authors.lastname: Naldi
mesh_terms: D000068879:Adalimumab; D016907:Adverse Drug Reaction Reporting Systems / Q000941:ethics / Q000458:organization & administration*; D000911:Antibodies, Monoclonal / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D015331:Cohort Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D005062:European Union; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects; D000069285:Infliximab; D007968:Leukoencephalopathy, Progressive Multifocal / Q000209:etiology / Q000276:immunology; D015201:Meta-Analysis as Topic; D009369:Neoplasms / Q000209:etiology / Q000276:immunology; D016017:Odds Ratio; D016032:Randomized Controlled Trials as Topic; D012306:Risk; D018570:Risk Assessment; D056737:Safety-Based Drug Withdrawals; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors; D014481:United States; D014486:United States Food and Drug Administration; D014944:World Health Organization
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab; C472181:efalizumab