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Avastin (bevacizumab) - Advisories, Warnings and Recalls for the Public
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(PDF Version - 67 K)Contact: Marketed Health Products Directorate (MHPD)
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 Hoffmann-La Roche Limited.
Contact the company for a copy of any references, attachments or enclosures.
PUBLIC COMMUNICATION Health Canada Endorsed Important Safety Information on Avastin (bevacizumab)
October 24, 2006
Subject: Association of AVASTIN® (bevacizumab) with hypertensive encephalopathy and reversible posterior leukoencephalopathy syndrome (RPLS)
Hoffmann-La Roche Limited, in consultation with Health Canada, has informed Canadian healthcare professionals of important new safety information concerning AVASTIN (bevacizumab).
AVASTIN is used in combination with a specific type of chemotherapy for the treatment of cancer of the bowel and rectum which has spread to other sites. Please note the following new safety information for the use of AVASTIN:
Hypertensive encephalopathy
Hypertensive encephalopathy is a complication of severe high blood pressure that affects the brain. Signs and symptoms are listed in the Table below. A total of three (3) confirmed cases of hypertensive encephalopathy have been reported worldwide following AVASTIN use. In all cases reported, patients had a medical history of very high blood pressure. One (1) case resulted in death. A direct cause and effect between AVASTIN and these events has not been established but cannot be ruled out. Hypertensive encephalopathy may be reversible if treated. AVASTIN should no longer be given to patients who develop this condition.
RPLS
RPLS is a rare brain disorder that can develop mostly in patients who have kidney failure, high blood pressure or who have a compromised immune system. Signs and symptoms are listed in the Table below. Four (4) confirmed cases and ten (10) suspected cases of RPLS have been seen worldwide following AVASTIN use. No cases have resulted in death. A direct cause and effect between AVASTIN and these events has not been established but cannot be ruled out. This syndrome may be reversible if recognised and treated promptly.
| Signs and symptoms of hypertensive encephalopathy may include: | Signs and symptoms of RPLS may include: |
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If you develop any of the above, contact your doctor or healthcare professional immediately.
Hoffmann-La Roche Limited has sent a letter to healthcare professionals informing them of this new safety information. A copy of the healthcare professional letter and this communication are available on the (Health Canada website).
The prescribing information for AVASTIN has been revised to include this updated information.
Hoffmann-La Roche Limited continues to work closely with Health Canada to monitor adverse event reporting and to ensure that up-to-date information regarding the use of AVASTIN is available. 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 serious or unexpected adverse reactions in patients receiving AVASTIN should be reported to Hoffmann-La Roche Limited, or Health Canada at the following addresses:
Drug Safety Department
2455 Meadowpine Boulevard
Mississauga, ON L5N 6L7
Call toll-free at 1-888-762-4388
Fax at: 905-542-5864
Email to: mississauga.drug_safety@roche.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
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.
For other inquiries related to this communication, please contact Health Canada at:Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Tel : (613) 954-6522
Fax : (613) 952-7738
Sincerely,
original signed by
Lorenzo Biondi,
Vice President, Medical and Regulatory Affairs
Hoffmann-La Roche Limited
