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This is duplicated text of a letter from Schering
Canada Inc..
Contact the company for a copy of any references, attachments or enclosures. |
PUBLIC ADVISORY
Health Canada Endorsed Important Safety Information on
REMICADE (infliximab) |
November 29, 2004
Pointe-Claire, QC, November 29, 2004 – Schering Canada Inc., in
cooperation with Health Canada, has informed healthcare professionals of
important information concerning Remicade (infliximab). Remicade belongs
to a class of products called tumor necrosis factor or TNF-blockers.
Remicade has been approved for use in Canada since 2001 for the treatment
of rheumatoid arthritis and Crohn’s disease. Please note the following
safety information:
- As with other TNF-blockers, malignancies have been associated with Remicade.
- The role of TNF-blockers in the development of malignancy is
not known at this time.
- In studies, patients treated with Remicade had a higher incidence
of a cancer of the immune system called lymphoma compared to the general
population*. However, the occurrence of lymphomas was rare.
- Patients with rheumatoid arthritis and Crohn’s disease
may also be at a higher risk of lymphoma than the general population,
even in the absence of TNF-blocking therapy.
* Refers to US general population
In Canada, a total of 14 cases of lymphomas possibly associated with Remicade
(infliximab) have been reported out of 27,611 patients who have taken the
drug since it was launched in 2001.
Signs and symptoms of lymphoma can vary depending on the extent of the
disease and parts of the body involved (e.g. chest, abdomen, bowel), however
common signs and symptoms of lymphoma may include the following:
Patients who experience these or any other unusual symptoms should contact
their physician.
- One or more enlarged lymph nodes;
- Unusual fatigue, fever, chills, night sweats, decreased appetite,
and weight loss.
The prescribing information for Remicade will be revised to include this
information on malignancies. Similar information is already included in
the prescribing information of the other drugs in this class of products.
This advisory is in addition to the letter issued to healthcare professionals
concerning this information. The letter can be accessed at Health Canada’s
website at http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/2004/index_e.html.
Schering Canada is a research-based pharmaceutical company based in Pointe-Claire,
Quebec and is a country operation of Schering-Plough Corporation.
For further information call Schering Canada Medical Services at (800)
463 5442 from 8:30 a.m. to 4:30 p.m. Monday to Friday, EST. For media inquiries,
call Kent Hovey-Smith, Schering Canada Inc., (514) 428-7475.
Any occurrences of serious and/or unexpected adverse reactions in patients
receiving REMICADE (infliximab) should be reported to Schering Canada,
Inc. or the Marketed Health Products Directorate at the following addresses:
Schering Canada, Inc.
3535 Trans-Canada Highway
Pointe-Claire, Quebec
H9R 1B4
Toll free Tel : (800) 463-5442 or Toll Free 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
For other inquiries: please refer to contact information.
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.
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