Canada - Acute allergic reactions including anaphylaxis, angioedema, urticaria and/or dyspnoea have been very rarely reported following intradermal skin testing with tuberculin purified protein derivative (Tubersol®).

These reactions may occur in persons without a prior history of a tuberculin skin test. Epinephrine hydrochloride solution (1:1000) and other appropriate agents should routinely be available for immediate use in case an anaphylactic or other acute hypersensitivity reaction occurs.

Health care providers should monitor the patient for immediate reactions for a period of at least 15 minutes after inoculation for the initial management of anaphylaxis (1).

The Canadian case reports contain such hypersensitivity events as anaphylactic reaction, angioedema, oedema, urticaria, throat swelling/ tightness, lip swelling, and hives, including in patients with no prior exposure to tuberculin. Health care professionals are directed to information in the product direction leaflet regarding the need for persons administering tuberculin skin tests to be prepared to treat an immediate systemic allergic reaction should one occur, and to monitor the patient for immediate reactions for a period of at least 15 minutes after inoculation.

References

1 Canadian Immunization Guide 2002. P. 14. http://www.phac-aspc.gc.ca/publicat/cig-gci/pdf/part1-cdn_immuniz_guide-2002-6.pdf

2. Communication from Sanofi Pasteur at http://www.sanofipasteur.ca and Health Canada website at http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_e.html 19 May 2005.