title: Off-label prescriptions for atopic dermatitis in Europe.
abstract: Moderate-to-severe forms of atopic dermatitis (AD) have a substantial impact on the quality of life of patients and their relatives, carrying a significant socioeconomic burden. They often require a systemic therapy, and ciclosporine A (CsA) is the only medicinal product approved for this indication in a limited number of European countries. However, due to the safety profile of CsA and its approval conditions, this treatment can only be prescribed for a limited period of time. Thus, moderate-to-severe forms of AD represent a significant unmet medical need and are subject to off-label prescriptions. Besides giving some insights into the approval procedures for medicinal products in the European Union, this short review is aimed to provide some relevant background information for off-label prescription in AD. It also provides a clinical algorithm for the off-label prescription of systemic immunosuppressants in AD, discusses the apparent dilemma between approval and guidelines, and finally suggests practical rules to be considered in the context of off-label prescription.
authors: Department of Dermatology and Allergy, Friedrich-Wilhelms-University, Bonn, Germany.
authors: T
authors: T
authors: Bieber
authors: B
authors: B
authors: Straeter
mesh_terms: D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D003876:Dermatitis, Atopic / Q000175:diagnosis / Q000188:drug therapy*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D005060:Europe; D006801:Humans; D056687:Off-Label Use / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000941:ethics; D012720:Severity of Illness Index
chemical_list: D018926:Anti-Allergic Agents
keywords: atopic dermatitis; off-label use; regulation; systemic therapy