Public Communication - Health Canada Endorsed Important Safety Information on Infanrix Hexa® Français
Subject: Voluntary recall of GlaxoSmithKline (GSK) Infanrix Hexa® Vaccine Lot A21CB242A due to potential contamination
MISSISSAUGA, ON, Nov. 2, 2012 /CNW/ - GlaxoSmithKline, in consultation with Health Canada, would like to inform you of its decision to voluntarily recall one Lot (A21CB242A) of Infanrix Hexa® vaccine as a result of detection of contamination in the environment where material used to make the recalled vaccine had been placed. No contamination was found in the vaccine.
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Infanrix Hexa® is a vaccine used in children for protection against diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and Haemophilus influenzae type b diseases. Vaccination is the best way to protect against these diseases.
Infanrix Hexa® is only currently offered through vaccination programs in British Columbia and the Yukon Territory.
Recent investigations detected contamination in the environment where one of the components of this Lot was placed.
A search of the GSK worldwide safety database did not identify any reported adverse events that appear to be linked to contamination. GSK has decided to initiate a voluntary recall of this Lot as a precautionary measure.
GlaxoSmithKline has sent a letter to healthcare professionals informing them about this recall. This information may be obtained on the Canadian website of GlaxoSmithKline (www.gsk.ca) or on the Health Canada Web site.
Should you have any questions or require additional information regarding the use of Infanrix Hexa® please contact your healthcare professional.
GSK sincerely apologizes for this situation and is working closely with health authorities to prevent any impact on children's immunization schedule.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse reactions in patients receiving Infanrix Hexa® should be reported to GSK or your local health department at the following addresses:
| GlaxoSmithKline Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4 Phone: 1-800-387-7374 How to report a suspected adverse event following immunization: Should you experience an adverse event following immunization, please ask your doctor, nurse, or pharmacist to complete the Adverse Events Following Immunization (AEFI) Form. The Adverse Events Following Immunization Reporting Form (http://www.phac-aspc.gc.ca/im/aefi-form-eng.php) and Guidelines (http://www.phac-aspc.gc.ca/im/aefi_guide/index-eng.php) can be found on the Public Health Agency of Canada Web site or in the Canadian Compendium of Pharmaceuticals and Specialties If you have any questions or have difficulties contacting your local health department, please contact the Vaccine Safety Section at the Public Health Agency of Canada at: Telephone: 613-954-5590, 1-866-844-0018 Fax: 613-954-9874, 1-866-844-5931 |
Sincerely,
Original signed by
Dr. Glenn Crater
Vice President, Medical and Chief Medical Officer
GlaxoSmithKline Inc.
| Provincial/Territorial Contacts for Adverse Events Following Immunization Form Alberta Alberta Health and Wellness Community Health Branch Immunization Program 10025 Jasper Ave NW P.O. Box 1360 Edmonton, AB T5J 2N3 Phone: 780-415-2824 Web site: www.albertahealthservices.ca/ British Columbia British Columbia Centre for Disease Control Epidemiology Services 655 West 12th Avenue Vancouver, BC V5Z 4R4 Phone: 604-707-2517 Fax: 604-707-2515 Web site: www.bccdc.ca Manitoba Manitoba Department of Health Communicable Disease Control Branch 4th Floor-300 Carlton Street Winnipeg, MB R3B 3M9 Phone: 204-788-6737 Fax: 204-948-3044 Web site: http://www.gov.mb.ca/health/publichealth/cdc/docs/aefi_form.pdf New Brunswick Communicable Disease Control (CDC) Branch Office of the Chief Medical Officer of Health Department of Health 2nd Floor HSBC Place, 520 King Street P.O. Box 5100 Fredericton, NB E3B 5G8 Main CDC Office Number: 506-444-3044 Web site: http://www2.gnb.ca/content/gnb/en/departments/ocmoh.html Newfoundland and Labrador Public Health Department of Health and Community Services P.O. Box 8700 St. John's NL A1B 4J6 Phone: 709-729-5019, 709-729-0115 Fax: 709-729-0730 Web site: http://www.health.gov.nl.ca/health/publichealth/cdc/immunizations.html Nova Scotia Department of Health and Wellness Summit Place, 6th Floor 1601 Lower Water Street P.O. Box 487 Halifax, NS B3J 2R7 Phone: 902-424-8160 Fax: 902-424-0550 Web site: http://www.gov.ns.ca/hpp/cdpc/ Northwest Territories Office of the Chief Medical Health Officer Department of Health and Social Services P.O. Box 1320 Yellowknife, NT X1A 2L9 Phone: 867-920-8646 Fax: 867-873-0442 Web site: http://www.hlthss.gov.nt.ca/default.htm Nunavut Office of the Chief Medical Health Officer Department of Health and Social Services P.O. Box 1000, Station 1000 Iqaluit, NU X0A 0H0 Phone: 867-975-5700 Fax: 867-979-3190 Ontario Direct all forms to your local public health unit. Contact information for each health unit can be found on the following Web page: http://www.health.gov.on.ca/english/public/contact/phu/phuloc_mn.html Phone: PHD Info line 1-866-532-3161 TTY: 1-800-387-5559 Prince Edward Island Office of Chief Health Officer Department of Health and Wellness P.O. Box 2000 Charlottetown, PEI C1A 7N8 Tel: 902-368-4996 Fax: 902-620-3354 Web site: http://www.gov.pe.ca/health/index.php3 Quebec Phone: Call Info Santé in your region Web site: http://www.msss.gouv.qc.ca/sujets/santepub/vaccination/index.php?accueil_en Saskatchewan Saskatchewan Ministry of Health Population Health Branch 3475 Albert Street Regina, SK S4S 6X6 Phone: 1-800-667-7766 Web site: http://www.health.gov.sk.ca/ Yukon Vaccine Program Manager Yukon Territorial Government Department of Health and Social Services #2 Hospital Road Whitehorse, YT Y1A 3H8 Phone: (867) 667-8330 Web site: http://www.hss.gov.yk.ca |
SOURCE: GLAXOSMITHKLINE INC.
For media inquiries, please contact GlaxoSmithKline Communications at (905) 819-3363.
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