Reply to the correspondence to the "Guideline for acute therapy and management of anaphylaxis".

Abstract

The authors of the guidelines [1] thank Drs. Rudolph and Fischer (InfectoPharm) for their comments [2] and would like to respond as follows: It is correct that the administration of 2 ml of a 1-mg/ml adrenaline solution in inhaled form, as stated in Tables 6 and 7, does not conform to the drug approval for ampules available on the market. The authors regret that they did not make explicit reference to this „off-label“ status. Possible side effects due to sulphite content should be of minor importance in an emergency setting. However, the alternative mentioned, i.e., inhaling with InfectoKrupp Inhal®, is similarly not approved for use in anaphylaxis. While it is also correct that an adrenaline solution is available for use in a nebulizer, this preparation is not – as mentioned above – approved for the treatment of anaphylaxis. The above-mentioned study by Breuer et al. [3] was commissioned by the manufacturer as a preclinical pilot study in eight healthy adults that used a nebulizer system of this kind. Said study had serum concentration as its sole endpoint and did not investigate the clinical effect of adrenaline. Thus, it is not possible to draw any valid conclusions on the efficacy of this method in the treatment of anaphylaxis. Furthermore, the preparation appears to be difficult to handle in an emergency setting to the extent that, following intense discussion, the guideline group decided against recommending it for this indication. In summary, it is correct that the off-label use of medicinal products should be explicitly mentioned in guidelines. This omission is hereby rectified. We express our thanks to Drs. Rudolph and Fischer for drawing our attention to this point. The recommendation regarding the described treatment procedure remains otherwise unchanged.