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Association of EPREX (epoetin alfa) with thrombotic vascular events - Janssen-Ortho Inc. - For The Public
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The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Janssen
Ortho Inc.
Contact the company for a copy of any references, attachments or
enclosures.
Health Canada Endorsed Important Safety Information on
EPREX (epoetin alfa)
Subject: Blood clot formation in cancer patients treated with EPREX (epoetin alfa) and similar medicines to higher than typical target hemoglobin levels in this population.
Toronto, October 18, 2004 - Janssen-Ortho Inc, in consultation with Health Canada, has informed Canadian healthcare professionals of important new safety information concerning EPREX (epoetin alfa) and other similar medicines. EPREX has been authorized for use in Canada since 1995 for the treatment of anemia in patients with cancer. Please note the following new safety information:
- Results of recent investigational studies using EPREX and other erythropoietin products have indicated an increased risk of blood clot formation in patients with cancer who were treated to raise their red blood cells to a level higher than the typical target in this population. In some cases, these blood clots were fatal.
Patients with cancer are generally at higher risk of blood clot formation than other patient populations as a result of known risk factors such as cancer itself, chemotherapy and radiation therapy.
Signs and symptoms of blood clot formation include:
- Weakness or numbness of the face, arms or legs and problems with speech or vision which may indicate a stroke (blood clot in the brain);
- Leg swelling, chest pain, shortness of breath or coughing up blood which may indicate a blood clot in the legs or lungs or a heart attack (blood clot in the blood vessels of the heart).
Janssen-Ortho has provided the revised prescribing information to healthcare
professionals across Canada. For more information about the revisions
to the prescribing information, patients should consult their healthcare
professional. This information is also available at 
http://www.janssen-ortho.com/
Patients should NOT discontinue their medication without consulting their
physician first.
As with all medicines, EPREX should not be used by anyone who does not require the drug to treat a disease or its symptoms.
This advisory is in addition to a letter issued to healthcare professionals discussing the above-mentioned safety information. This letter can be accessed at Health Canada's web site
Janssen-Ortho Inc., is a research-based pharmaceutical company located in Toronto.
For further information: Simone Philogène, Janssen-Ortho Inc.,
(416) 449-9444. Or call the Janssen-Ortho Medical Information Department
at 1-800-567-3331, from 9 a.m. to 5 p.m. Monday to Friday, EST.
The identification, characterization, and management of marketed health
product-related adverse reactions are dependent on the active participation
of health care professionals in adverse reaction reporting programmes.
Any occurrences of blood clot formation or other serious and/or unexpected
adverse reactions in patients receiving EPREX should be reported to
Janssen-Ortho Inc or Health Canada at the following addresses:
Janssen-Ortho Inc.
Drug Safety and Surveillance
19 Green Belt Drive
Toronto, ON M3C 1L9 or call toll free at 1-800-567-3331
email to dsscan@joica.jnj.com
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.
*All trademark rights used under license
Original signed by
Wendy Arnott, Pharm.D.
Vice President
Regulatory, Safety and Quality
