Reported Adverse Drug Reaction Cases
Patent blue V and anaphylaxis
Patent Blue V (occasionally referred to as Sulphan Blue) is a dye used to colour lymph vessels. In lymphangiography, Patent Blue V is injected subcutaneously so it can enter the lymphatic vessels, which are then visible through the skin and can be injected with a radiological contrast agent. Patent Blue V is being increasingly used for a number of purposes including breast surgery, where it is injected into breast tissue in order to locate draining lymph nodes.
Over the years ADRAC has received 42 reports of reactions to Patent Blue V, including six reports of anaphylaxis. Five of these have been reported since October 2000 and were in women aged 37-54 years, undergoing breast surgery. In four cases, the anaphylaxis was described as severe; two patients required admission to an Intensive Care Unit. Past exposure to Patent Blue V was generally not recorded, but is probably unlikely. One patient had a history of cold urticaria. Most recovered without sequelae.
Surgeons and anaesthetists should be aware of the potential for severe allergic reactions to Patent Blue V. The Product Information recommends testing for hypersensitivity by injecting a small volume of solution initially, then waiting a short time to see if an allergic reaction develops.