SIDE EFFECTS

Anaphylaxis during sublingual immunotherapy

A 50-year-old woman with hay fever and asthma had been taking the allergy preparation GRAZAX for almost four months when an anaphylactic reaction occurred when she had a cold. Immediately after use of the sublingual tablets, which contain timothy grass pollen, the patient complained of predominantly truncal itching, urticaria, rhinorrhoea and shortness of breath. The symptoms disappeared within one day following the administration of peroral glucocorticoids and the repeated inhalation of sympathomimetic drugs. Following an improvement in the symptoms of the cold, the allergen preparation was once again well tolerated (NETZWERK report 17.386). We have two further reports of angioedema and shortness of breath occurring along with other symptoms shortly after consumption of the sublingual allergen extract ORALAIR, which contains timothy grass and other grass pollens (NETZWERK reports 15.613 and 16.945). In the past five years, the European Medicines Agency (EMA) has documented 45 reports of suspected anaphylactic reactions following sublingual immunotherapy with timothy grass pollens in its databases, nine of which were life-threatening (1). German Summaries of Product Characteristics (SPCs) for GRAZAX and ORALAIR make reference to severe allergic (2) or anaphylactic (3) reactions with symptoms such as flush, itching, urticaria, angioedema, dysphagia, dyspnoea, a drop in blood pressure or a feeling of narrowing in the throat and state that treatment should be stopped or interrupted and medical help sought immediately if these symptoms occur. The first use of the allergen preparations should be under medical supervision, and patients should then be monitored for around 30 minutes (2, 3). Life-threatening allergic reactions may, however, occur after the first day of treatment (3-5). Post-marketing reports made to the US Food and Drug Administration (FDA) also indicate that those patients who were excluded from clinical trials such as those with moderate or severe asthma who are reliant on the daily inhalation of corticosteroids and those with prior cardiac or pulmonary disease (4, 5) are affected in particular. Sublingual immunotherapy with GRAZAX or ORALAIR can therefore only be given in the US if the patient is also prescribed adrenalin auto-injectors (e.g. FASTJEKT) (4-7).

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