Fatal reactions related to subcutaneous allergen immunotherapy are rare: one event in 2.5 million injections has been reported in the USA and none in Europe. The prevalence of very severe systemic reactions (systemic adverse events [SAEs]) is one in 1 million injections. Though the serious events rate is decreasing and the majority of SAEs (∼0.2% per injection) are moderate and reversible, they still represent a major concern. Uncontrolled asthma, long-term therapy with β-blockers and high degree of allergen sensitivity are generally considered risk factors. The relevance of other conditions, like previous local reactions, the use of extracts conjugated with adjuvants and accelerated build-up schedules is controversial, as well as the role of preventative strategies. A careful risk assessment of patients and optimal administration procedures may significantly decrease the risk of SAEs. However, more uniform safety data are required and an accurate safety profile should be provided for every allergen product.
Keywords: allergen immunotherapy; anaphylaxis; local reactions; risk factor; safety; subcutaneous; systemic reactions.