- Medicines and Healthcare products Regulatory Agency
- Therapeutic area:
- Cancer and Radiology and imaging
Surgeons reminded to have competent personnel and emergency facilities available for at least 1 hour after administration of the blue dye.
Article date: February 2012
Blue dyes such as Patent Blue V imported from the EU are used in lymphatic mapping for sentinel lymph node biopsy (SLNB) in breast surgery. Patent Blue V does not carry a UK marketing authorisation.
On the basis of a clinical study (the ALMANAC trial)1 and follow-up program (the NEW START program) serious allergic reactions were estimated at an incidence rate of 0.1%. Since 1975 a total of 70 case reports of allergic reactions with Patent Blue V were reported to us. 58 of these reports have been received since 2007, 26 of which were serious reactions. With currently increasing usage of Patent Blue V in the UK, the number of serious allergic reactions reported to us is also expected to rise.
The UK Pharmacovigilance Expert Advisory Group of the Commission on Human Medicines advised that emergency measures should be available to treat patients that may experience allergic reactions or anaphylaxis.
Advice for healthcare professionals:
- surgeons using blue dyes are reminded to remain aware of the risk of serious allergic reactions, including anaphylaxis
- competent personnel and emergency facilities should be available for at least 1 hour after administration of blue dye because delayed reactions may occur
- please report suspected adverse reactions via the Yellow Card scheme (www.mhra.gov.uk/yellowcard) even though blue dyes are unlicensed products, and include the seriousness of the reported reaction
Prescribers’ responsibilities regarding off-label or unlicensed use of medicines
Article citation: Drug Safety Update Feb 2012 vol 5, issue 7: A2.
Mansel RE, et al. J Natl Cancer Inst 2006; 98: 599–609. ↩