Adverse reactions to patent blue V dye - The NEW START and ALMANAC experience

Abstract

Background: Blue dye with or without isotope has been widely used to identify the sentinel lymph node(s) in breast cancer. Patent blue V is used in the UK while its isomer isosulfan blue is used in the US. The allergic potential of isosulfan blue is well documented (1.4% adverse reactions) but that of patent blue V is less clearly defined.

Methods: In this paper we review the adverse reactions of patent blue V in 7,917 patients who participated in the NEW START training programme and the ALMANAC trial. All patients underwent sentinel lymph node biopsy for breast carcinoma using patent blue V in combination with (99m)Tc-albumin colloid.

Results: In total, 72 of 7,917 (0.9%) patients experienced adverse reactions : non-allergic reactions were observed in 4 (0.05%) patients, 23 (0.3%) patients had minor grade I allergic skin reactions (urticaria, blue hives, pruritus, or generalised rash) and 16 (0.2%) had grade II reactions (transient hypotension/bronchospasm/laryngospasm). Severe Grade III reactions (severe hypotension requiring vasopressor support and/or change/abandoning of planned procedure and/or HDU/ITU admission) were noted in 5 (0.06%) patients. The type of adverse reaction was not specified in 24 (0.3%) patients. No mortality was recorded.

Conclusion: The allergic potential of patent blue V dye compares favourably with isosulfan blue however both the surgeon and anaesthetist need to be alert to the risk of allergic reactions.