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


CONCLUSIONS
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.
Barthelmes
L
L
Department of Surgery, School of Medicine, Cardiff University, Cardiff, UK.
Goyal
A
A
Newcombe
R G
RG
McNeill
F
F
Mansel
R E
RE
D001943:Breast Neoplasms / Q000473:pathology*; D004396:Coloring Agents / Q000009:adverse effects*; D004342:Drug Hypersensitivity / Q000453:epidemiology*; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D016032:Randomized Controlled Trials as Topic; D012394:Rosaniline Dyes / Q000009:adverse effects*; D021701:Sentinel Lymph Node Biopsy / Q000009:adverse effects* / Q000379:methods; D006113:United Kingdom / Q000453:epidemiology
D004396:Coloring Agents; D012394:Rosaniline Dyes; C025484:iso-sulfan blue; C008769:sulfan blue