title: Guideline for the diagnosis of drug hypersensitivity reactions: S2K-Guideline of the German Society for Allergology and Clinical Immunology (DGAKI) and the German Dermatological Society (DDG) in collaboration with the Association of German Allergologists (AeDA), the German Society for Pediatric Allergology and Environmental Medicine (GPA), the German Contact Dermatitis Research Group (DKG), the Swiss Society for Allergy and Immunology (SGAI), the Austrian Society for Allergology and Immunology (ÖGAI), the German Academy of Allergology and Environmental Medicine (DAAU), the German Center for Documentation of Severe Skin Reactions and the German Federal Institute for Drugs and Medical Products (BfArM).
abstract: Drug hypersensitivity reactions are unpredictable adverse drug reactions. They manifest either within 1-6 h following drug intake (immediate reactions) with mild to life-threatening symptoms of anaphylaxis, or several hours to days later (delayed reactions), primarily as exanthematous eruptions. It is not always possible to detect involvement of the immune system (allergy). Waiving diagnostic tests can result in severe reactions on renewed exposure on the one hand, and to unjustified treatment restrictions on the other. With this guideline, experts from various specialist societies and institutions have formulated recommendations and an algorithm for the diagnosis of allergies. The key principles of diagnosing allergic/hypersensitivity drug reactions are presented. Where possible, the objective is to perform allergy diagnostics within 4 weeks-6 months following the reaction. A clinical classification of symptoms based on the morphology and time course of the reaction is required in order to plan a diagnostic work-up. In the case of typical symptoms of a drug hypersensitivity reaction and unequivocal findings from validated skin and/or laboratory tests, a reaction can be attributed to a trigger with sufficient confidence. However, skin and laboratory tests are often negative or insufficiently reliable. In such cases, controlled provocation testing is required to clarify drug reactions. This method is reliable and safe when attention is paid to indications and contraindications and performed under appropriate medical supervision. The results of the overall assessment are discussed with the patient and documented in an "allergy passport" in order to ensure targeted avoidance in the future and allow the use of alternative drugs where possible.
authors.affiliation: Department of Dermatology and Allergology Biederstein, Technical University of Munich, Biedersteiner Straße 29, 80802 Munich, Germany.
authors.forename: Knut
authors.initials: K
authors.lastname: Brockow
authors.affiliation: Department of Dermatology and Allergology, Allergy Center, Ludwig Maximilian University of Munich, Munich, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Przybilla
authors.affiliation: Department of Dermatology, Medical University of Graz, Graz, Austria.
authors.forename: Werner
authors.initials: W
authors.lastname: Aberer
authors.affiliation: Department of Allergology, University Hospital Basle, Basle, Switzerland.
authors.forename: Andreas J
authors.initials: AJ
authors.lastname: Bircher
authors.affiliation: Department of Dermatology, Münster University Hospital, Münster, Germany.
authors.forename: Randolf
authors.initials: R
authors.lastname: Brehler
authors.affiliation: Department of Dermatology, Venereology and Allergology, St. Josef Hospital, Ruhr University Bochum, Bochum, Germany.
authors.forename: Heinrich
authors.initials: H
authors.lastname: Dickel
authors.affiliation: Department of Dermatology, Venereology and Allergology, Göttingen University Hospital, Göttingen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Fuchs
authors.affiliation: Department of Dermatology and Venereology, Freiburg University Hospital, Freiburg, Germany.
authors.forename: Thilo
authors.initials: T
authors.lastname: Jakob
authors.affiliation: Department of Pediatrics, Marien Hospital Bonn, Bonn, Germany.
authors.forename: Lars
authors.initials: L
authors.lastname: Lange
authors.affiliation: Department of Dermatology and Allergology, Gießen and Marburg University Hospital, Marburg, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Pfützner
authors.affiliation: German Center for the Documentation of Severe Skin Reactions, Department of Dermatology and Venereology, Freiburg University Hospital, Freiburg, Germany.
authors.forename: Maja
authors.initials: M
authors.lastname: Mockenhaupt
authors.affiliation: Children's and Adolescents' Hospital "Auf der Bult,", Hannover, Germany.
authors.forename: Hagen
authors.initials: H
authors.lastname: Ott
authors.affiliation: ENT at Mannheim University Hospital, Center for Rhinology and Allergology, Wiesbaden, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Pfaar
authors.affiliation: Department of Dermatology and Allergology Biederstein, Technical University of Munich, Biedersteiner Straße 29, 80802 Munich, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Ring
authors.affiliation: Federal Institute for Drugs and Medicinal Products, Bonn, Germany.
authors.forename: Bernhardt
authors.initials: B
authors.lastname: Sachs
authors.affiliation: Institute of Theoretical Surgery, Philipps University, Marburg, Germany.
authors.forename: Helmut
authors.initials: H
authors.lastname: Sitter
authors.affiliation: Department of Dermatology and Allergology, Mainfranken Allergy, Würzburg University Hospital, Würzburg, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Trautmann
authors.affiliation: Department of Dermatology, Venereology and Allergology, Leipzig University, Leipzig, Germany.
authors.forename: Regina
authors.initials: R
authors.lastname: Treudler
authors.affiliation: Department of Dermatology, Venereology and Allergology, Hannover Medical University, Hannover, Germany.
authors.forename: Bettina
authors.initials: B
authors.lastname: Wedi
authors.affiliation: Department of Dermatology, Venereology and Allergology, Charité University Hospital, Berlin, Germany.
authors.forename: Margitta
authors.initials: M
authors.lastname: Worm
authors.affiliation: Department of Dermatology and Allergology, RTWH Aachen, Aachen, Germany.
authors.forename: Gerda
authors.initials: G
authors.lastname: Wurpts
authors.affiliation: Department of Dermatology, Venereology and Allergology, Charité University Hospital, Berlin, Germany.
authors.forename: Torsten
authors.initials: T
authors.lastname: Zuberbier
authors.affiliation: Department of Dermatology and Allergology, RTWH Aachen, Aachen, Germany.
authors.forename: Hans F
authors.initials: HF
authors.lastname: Merk
keywords: diagnosis; drug hypersensitivity; in vitro test; provocation test; skin test