Allergic reactions to patent blue dye V – the ALMANAC and NEW START experience (on behalf of the ALMANAC study group).
Authors: Barthelmes L , Mansel RE 
Published: December 2010

Abstract
Abstract #1001
Background and methods&#x2028; Single reports of allergic reactions following injection of patent blue dye V - an isomer of isosulfan blue - as part of the sentinel node procedure have been well documented in small series. We report analysis from the systematic and prospective data collection of 5853 sentinel node biopsies as part of the ALMANAC trial (J Natl Cancer Inst 2006; 98(9):599-609) and NEW START sentinel node training program that has subsequently been rolled out in the UK. Prospective data collection includes documentation of side-effects after injection of patent blue dye V. The participating surgeon can specify the reaction in a free-text box. We summarised the specified reactions into local skin, allergic and cardiovascular reactions. We also charted whether the reactions necessitated any drug treatment (histamine antagonist, steroids or adrenaline / ephedrine) or triggered admission to the intensive care unit or a change of the procedure. Allergic reactions were classified into grade I (urticaria, blue hives +/- generalised rash), grade II (transient hypotension not requiring vasopressor support) and grade III (severe hypotension requiring vasopressor support).&#x2028; Results&#x2028; 51 of 5853 (0.9 %) patients experienced 77 reactions to patent blue dye V. In 16 patients the type of reaction was not further specified. 5 patients were noted to have intense localised skin staining. Interestingly, 3 surgeons independently noted blue wheals distal to the blood pressure cuff. 21 patients experienced minor (grade I) allergic skin reactions. One was treated with hydrocortisone only, one with a histamine antagonist only, 6 with hydrocortison and a histamine antagonist. Grade II allergic reactions – transient hypotension not requiring vasopressor support – occurred in 4 patients, one of whom developed bronchospasm. 2 patients experienced grade III allergic reactions – severe hypotension treated with vasopressors. In 2 further patients the severity of the allergic reaction led to a change of the proposed procedure. In one patient who developed severe hypotension immediately after administration of patent blue dye V the procedure was abandoned. The patient was admitted to the intensive care unit for observation overnight but recovered without any sequelae. Another patient – who was in the ALMANAC audit phase where the sentinel node procedure was followed by the unit's conventional surgery - developed arrhythmias. The patient was meant to undergo an axillary node clearance but this was changed to axillary sampling as the final staging procedure.&#x2028; Conclusion&#x2028; Minor reactions after patent blue dye V injection are uncommon and were noted in 51 of 5853 (0.9 %) sentinel node biopsies. Severe allergic reactions requiring either vasopressor support or a change / abandoning of the procedure are even rarer - 4 of 5853 (0.07 %) procedures. It is, however, important that surgeon, anaesthetist and the unit are prepared for this eventuality.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 1001.