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TYSABRI (natalizumab) - New Safety Information Regarding Progressive Multifocal Leukoencephalopathy (PML) - For the Public
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(PDF Version - 322 K) Contact: Marketed Health Products Directorate
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 Biogen Idec Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.
Public Communication
Health Canada Endorsed Important Safety Information on TYSABRI (natalizumab)
May 12, 2010
Subject: New Information on the risk of Progressive Multifocal Leukoencephalopathy (PML) with TYSABRI® (natalizumab)
Biogen Idec Canada Inc., in consultation with Health Canada, has informed Canadian healthcare professionals of an important update to safety information concerning TYSABRI (natalizumab).
TYSABRI is authorized for the treatment of patients with a form of multiple sclerosis (MS) called relapsing-remitting (periods of symptoms alternating with periods without symptoms).
- PML is a serious disabling neurological condition that can result in death.
- The risk of PML increases the longer you are receiving treatment, especially if you have been on treatment for over 24 months. The risk after 3 years of treatment is currently unknown.
- Persons taking TYSABRI are to enroll in the TYSABRI Care Program™.
Rare cases of a brain infection by JC virus called progressive multifocal leukoencephalopathy (PML) have occurred in patients who have been given TYSABRI. PML can cause disability or death. PML usually happens in people with weakened immune systems. Signs and symptoms of PML include progressive weakness on one side of the body, clumsiness of limbs, disturbance of vision, changes in thinking, memory and orientation, confusion, and personality changes. Some of the symptoms are similar to MS, so if you develop any of these symptoms or any other unusual symptoms, or if your MS gets worse, contact your doctor immediately.
The prescribing information for TYSABRI has been updated to include more information on PML. The prescribing information is available by contacting the Tysabri Care Program™ at 1-888-827-2827.
TYSABRI is generally recommended in MS patients who have not responded to, or cannot tolerate other treatments for MS, and should not be used in combination with other medicines that affect the immune system.
In order to receive TYSABRI you must talk to your doctor and understand the benefits and risks of TYSABRI and consent to receiving treatment. You are to enrol in the TYSABRI Care Program™. After 24 months of treatment you should again talk to your doctor, understand the benefits and risks of TYSABRI treatment and consent to continuing treatment.
Managing marketed health product-related adverse reactions depends on healthcare professionals and consumers reporting them. Any serious or unexpected adverse reactions in patients receiving TYSABRI should be reported to the Tysabri Care Program™ or Health Canada at the following addresses:
Phone: 1-888-827-2827
Biogen Idec Canada Inc.
90 Burnhamthorpe Road West, Suite 1100
Mississauga, ON L5B 3C3
Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701E
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
CanadaVigilance@hc-sc.gc.ca
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 1-866-234-2345
Fax: 1-866-678-6789
Postage paid labels, the Canada Vigilance Reporting Forms and the Adverse Reaction Reporting Guidelines can be found on the MedEffectTM Canada Web site in the Adverse Reaction Reporting section. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.
For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738
To change your mailing address or fax number, contact the Market Authorization Holder (industry).
Sincerely,
original signed by
Dr. Len Walt M.D., M.B.A.
Medical Director
