Correspondence to the “Guideline for acute therapy and management of anaphylaxis”

It was with great interest that we followed the updated version of the “Guideline for acute therapy and management of anaphylaxis” published in the May issue of the Allergo Journal [1]. As the manufacturers of a variety of adrenaline preparations used for, amongst others, the treatment of anaphylaxis, we would like to draw attention to a number of recommendations in the guideline that, in our opinion, require critical scrutiny: In Tables 6 and 7 (pharmacotherapy for children, adolescents and adults), the use of an „original concentration (1 mg/ml)“ is recommended for the administration of inhaled adrenaline. Similarly, the „administration of adrenaline“ (e.g., 2 ml at 1 mg/ ml) via a nebulizer is recommended in the guideline text. However, there is no mention in the guideline that the available adrenaline solutions at a concentration of 1 mg/ml (adrenaline 1:1.000 Infectopharm; Suprarenin®) are not approved for inhaled use and, moreover, contain sulphites. Yet in Germany, the product InfectoKrupp Inhal® in a 4-mg/ml concentration represents an adrenaline product that does have drug approval. Why the guideline gives preference here to the o label use of parenteral adrenaline over the administration of a preparation approved for inhaled use is not speci ed in more detail. However, we consider it misleading to recommend the o -label use of emergency medication in an o cial guideline without stating the rationale for this, while at the same time failing to mention that an alternative medication with drug approval is available. In the case of liability, any physician following this recommendation will nd himself legally in a di cult position. In Table 8, moreover, you recommend including a preparation with a spray head for pharmaceutical vials in the „emergency set for self-help“ for those patients in whom airway obstruction is to be expected. e only adrenaline preparation (InfectoKrupp Inhal®) approved for inhaled use in Germany is a solution for use in a nebulizer. Here again, the use of a spray head on a pharmaceutical vial is an o label recommendation. In the past, a suitable spray head was used for reasons of practicability, since small, convenient electric nebulizer systems enabling mobile use were not available. However, a number of compact, battery-powered and even reimbursable nebulizers have been available for several years now, permitting the preparation to also be inhaled in a mobile setting (e.g., InfectoPharm pocket nebulizer, Omron-U22®). One study showed that relevant epinephrine plasma concentrations were achieved in healthy adults by inhaling InfectoKrupp Inhal using a mobile nebulizer [2]. No comparable study data are available for spray systems. We are aware that anaphylaxis represents a medical emergency requiring rapid action and speed and practicability in terms of using a drug may sometimes be more important than drug approval. Nevertheless, we would like to expressly point out here that, under the current legal framework, explicit reference should be made to o -label use and, where available, an approved alternative named in the guideline. A reference to o -label use is a er all made in the guideline in relation to the use of autoinjectors in children weighing between 10 and 15 kg. Naturally, we would be happy to engage in a more in-depth discussion of the above. Above this, we would kindly request that these points be recti ed in the next guideline update.