Guideline for the diagnosis of drug hypersensitivity reactions

Knut Brockow, Bernhard Przybilla, Werner Aberer, Andreas J. Bircher, Randolf Brehler, Heinrich Dickel, Thomas Fuchs, Thilo Jakob, Lars Lange, Wolfgang Pfützner, Maja Mockenhaupt, Hagen Ott, Oliver Pfaar, Johannes Ring, Bernhardt Sachs, Helmut Sitter, Axel Trautmann, Regina Treudler, Bettina Wedi, Margitta Worm, Gerda Wurpts, Torsten Zuberbier, Hans F. Merk

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.