Advisory
2003-102
December 18, 2003
For immediate release
Important safety information about the risk of liver injury in patients taking beta-interferon therapy
OTTAWA - Health Canada, in consultation with Biogen Idec Canada, Berlex Canada, and Serono Canada, has informed Canadian health care professionals of new safety information concerning beta-interferon therapy for the treatment of multiple sclerosis in a clinical setting. The beta-interferon injectable products include:
AVONEX® (interferon beta-1a) |
Biogen Idec Canada, Inc. |
BETASERON® (interferon beta-1b) |
Berlex Canada, Inc. |
REBIF® (interferon beta-1a) |
Serono Canada, Inc. |
Serious liver injury (e.g. hepatitis) has been reported in association with beta-interferon therapy, including three cases of liver failure that required liver transplantation. Serious liver injury is considered rare, with cases mostly occurring in the early months of therapy but also in patients on therapy beyond one year.
Treating physicians should perform periodic liver function tests, particularly in the early months of therapy, and patients receiving beta-interferon products should be aware of the signs and symptoms of liver injury, including:
- yellowing of the skin or eyes (jaundice)
- nausea and vomiting
- easy bruising of the skin
- diffuse itching
- abdominal pain
Should patients experience any of these symptoms, they should contact their physician immediately.
This advisory is in addition to a letter issued to health care professionals discussing the above-mentioned safety information. This letter can be accessed at Health Canada's Web site (www.hc-sc.gc.ca/fn-an/advisories-avis/index_e.html), as well as the company Web sites: www.berlex.ca and www.serono-canada.com . In addition, the prescribing information (Product Monographs) for the beta-interferon products are being revised to provide physicians and pharmacists with updated safety information regarding liver injury.
Patients who have any questions about their current prescription should contact their physician or pharmacist directly.
Suspected adverse reactions can be reported directly to the following addresses:
AVONEX®
Biogen Idec Canada Inc.
3 Robert Speck Parkway,
Suite 300
Mississauga, ON
L4Z 2G5
Tel: (905) 897-3234
Fax: (905) 897-3222
Attention: Medical Services
BETASERON®
Berlex Canada, Inc.
334, avenue Avro
Pointe Claire, QC
H9R 5W5
Tel: (800) 361-0240
Fax: (514) 782-2234
REBIF®:
Serono Canada, Inc.
1075 North Service Road West
Suite 100
Oakville, Ontario
L6M 2G2
Tel: 888-737-6668
Fax: 905-825-3209
Avonex® is a registered trademark of Biogen Idec, Inc.
Betaseron® is a registered trademark of Schering AG.
Rebif® is a registered trademark of Serono, Inc.
Any suspected adverse reactions can also be reported to:
Canadian Adverse Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
Cadrmp@hc-sc.gc.ca
The ADR Reporting Form and the ADR Guidelines can be found in The Canadian Compedium of Pharmaceutical and Specialties, or on the TPD website at:
www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index_e.html
www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/guide/index_e.html
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Media Inquiries:
Emmanuel Chabot
Health Canada
(613) 957-1803
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