title: Monitoring the safety of medicines used off-label.
abstract: Off-label use of medicines is common. Because many off-label uses have not been carefully studied, it is important that postmarketing drug safety systems be able to identify, assess, and monitor adverse events that occur in the off-label setting. The full range of postmarketing surveillance and analysis tools can be utilized to study the adverse effects of medicines used off-label.
authors.affiliation: Office of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, Maryland, USA. gerald.dalpan@fda.hhs.gov
authors.forename: G J
authors.initials: GJ
authors.lastname: Dal Pan
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D056687:Off-Label Use