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Letter Warns of Hepatitis B Reactivation Associated with Anti-TNF alpha Products

OTTAWA, CANADA -- January 18, 2006 -- Amgen Canada, Abbott Laboratories, and Schering Canada have sent out a letter to health care professionals in consultation with Health Canada regarding their anti-TNF alpha products Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab).

The focus of the letter is updated safety information regarding the anti-TNF alpha therapies Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab), which are authorized for sale in Canada.

Enbrel (etanercept, Immunex Corporation, Distributor: Amgen Canada, Inc.) is approved for treatment of rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, chronic plaque psoriasis.

Humira (adalimumab, Abbott Laboratories, Ltd.) is approved for treatment of rheumatoid arthritis,

Remicade (infliximab, Centocor, Inc., Distributor: Schering Canada, Inc.) is approved for treatment of rheumatoid arthritis, crohn's disease, and ankylosing spondylitis.

Based on review of recent post-marketing reports:

Hepatitis B virus (HBV) reactivation has been reported very rarely in patients with chronic hepatitis B infection receiving the anti-TNF alpha agents Enbrel, Humira, and Remicade, the letter states.

Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating anti-TNF alpha therapy. Those identified as chronic HBV carriers (i.e. surface antigen positive) should be monitored for signs and symptoms of active HBV infection throughout the course of therapy and for several months following discontinuation of therapy.

Reactivation of HBV is not unique to anti-TNF alpha agents and has been reported with other immunosuppressive drugs, the letter states.

Very rare cases (less than 1 adverse event per 10,000 treated patients) of HBV reactivation associated with anti-TNF alpha therapy have been reported cumulatively, with one (1) report originating from Canada, according to the letter. Clinically active HBV infection occurred following a latency period ranging from 3 weeks to 20 months after initiation of therapy. In the majority of cases, patients were also being treated with other immunosuppressive drugs, including methotrexate, azathioprine, and/or corticosteroids. Hence, establishing a direct causal relationship to anti-TNF alpha agents is confounded by the presence of these other medications.

Where outcome information was provided, most patients were reported to have improved after antiviral treatment and/or discontinuation of the anti-TNF alpha agent. However, fatal outcomes have also occurred in reported cases, the letter states.

The Canadian Product Monographs for Enbrel, Humira, and Remicade are being revised to include the above updated safety information.

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 HBV reactivation or other serious or unexpected adverse reactions in patients receiving Enbrel, Humira, or Remicade should be reported to Amgen Canada, Inc., Abbott Laboratories, Ltd., or Schering Canada, Inc., respectively, or Health Canada at the following addresses:

Enbrel
Amgen Canada, Inc. (on behalf of Immunex Corporation)
6755 Mississauga Road, Suite 400
Mississauga, Ontario L5N 7Y2
Tel: (866) 512-6436
Fax: (888) 264-3655

Humira
Abbott Laboratories, Limited
Medical Information Department
8401 Trans-Canada Highway
Saint-Laurent, Quebec H4S 1Z1
Tel : 1-800-567-2226
Fax : (514) 832-7824

Remicade
Schering Canada, Inc. (on behalf of Centocor, Inc.)
3535 Trans-Canada Highway
Pointe Claire, Quebec, H9R 1B4
Tel: (800) 463-5442
Fax: (800) 369-3090

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
cadrmp@hc-sc.gc.ca

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.

Other inquiries related to this communication should be addressed to Health Canada at:
Marketed Health Products Directorate
E-mail: MHPD_DPSC@hc-sc.gc.ca
Tel: (613) 954-6522
Fax: (613) 952-7738


SOURCE: Health Canada

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