Archived – Risk of Serious Allergic Reactions Following TUBERSOL [Tuberculin Purified Protein Derivative (Mantoux)] Administration – For Health Professionals

Health Canada Endorsed Important Safety Information on TUBERSOL^® [Tuberculin Purified Protein Derivative (Mantoux)]

19 May 2005

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

Dear Health Care Professional,

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 distributed^{Footnote 1}.

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.

It should be noted that reporting rates determined on the basis of spontaneously reported post-market adverse events are generally presumed to underestimate the risks associated with the use of health products. In addition, reporting requirements may differ between countries, and data arising from several unique surveillance systems cannot be compared directly.

The identification, characterization, and management of marketed health product-related adverse events are dependent on the active participation of health care professionals in adverse drug reaction reporting programmes. Any occurrences of serious allergic reactions or other serious and/or unexpected adverse events in patients receiving TUBERSOL^® should be reported to Aventis Pasteur Limited or Health Canada at the following addresses:

Global Pharmacovigilance Department
Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario M2R 3T4
Tel: 1-888-621-1146 or Fax: 416-667-2435

Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
Email: cadrmp@hc-sc.gc.ca

For other inquiries, please refer to contact information:
Marketed Health Products Directorate
Email: MHPD_DPSC@hc-sc.gc.ca
Tel: (613) 954-6522, Fax: (613) 952-7738

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

If you have questions regarding this letter please contact the Vaccine Information Service, Aventis Pasteur Limited by phone at 416-667-2779 or toll free at 1-888-621-1146. A copy of this letter is also available on the sanofi pasteur web site and in the "Advisories and Warnings" section of the Health Canada web site.

Sincerely,

original signed by

Pierre Lavigne, MD
Director, Medical Affairs
Sanofi Pasteur Limited