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Risk of Serious Allergic Reactions Following TUBERSOL [Tuberculin Purified Protein Derivative (Mantoux)] Administration

May 19, 2005 | Health Canada Sanofi Pasteur Limited (formerly known as Aventis Pasteur Limited), in consultation with Health Canada and the Public Health Agency of Canada (PHAC), draws your attention to the potential for serious allergic reactions with the use of TUBERSOL.

Acute allergic reactions including anaphylaxis, angioedema, urticaria and/or dyspnea have been very rarely reported following intradermal skin testing with 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 be familiar with the current recommendations of the National Advisory Committee on Immunization (NACI) for monitoring the patient for immediate reactions for a period of at least 15 minutes after inoculation and for the initial management of anaphylaxis in non-hospital settings (Canadian Immunization Guide).

During the period from January 1993 through January 2005 more than 360 million doses of TUBERSOL were distributed worldwide with 14 million in Canada alone. During this period, 9 reports of serious allergic reactions and/or allergic-related symptoms temporally associated with tuberculin skin testing were received from Canadian sources and 17 reports internationally, a rate of less than 1 report per million doses distributed.

This is less than the rate of anaphylaxis reported in the Canadian post-marketing surveillance system for vaccine-associated adverse events, which ranges from 1.1 to 3.1 reports per million doses distributed1.

Reminder to Health Professionals:

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 TUBERSOL 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.

This precaution is meant to apply whenever TUBERSOL is administered. Health Canada suggests that the previous direction leaflet may have been potentially misinterpreted by some to imply that this precaution was only required for those previously exposed to TUBERSOL or its components.

This clarification has been included in an updated product monograph and direction leaflet that was recently approved by Health Canada.

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