Archived - Association of Macugen (pegaptanib sodium injection) with hypersensitivity reactions

Starting date:

January 12, 2006

Posting date:

January 23, 2006

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001415

This is duplicated text of a letter from Pfizer Canada Inc.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on Macugen* (pegaptanib sodium injection)

January 12, 2006

Dear Ophthalmologist:

Subject: Association of Macugen* (pegaptanib sodium injection) with reports of hypersensitivity reactions, including anaphylaxis/anaphylactoid reactions

Pfizer Canada Inc., after discussion with Health Canada, would like to provide you with important safety information for MACUGEN (pegaptanib sodium injection), regarding post-marketing reports of hypersensitivity reactions including anaphylaxis/anaphylactoid reactions.

• Ophthalmologists using MACUGEN should be aware of the potential for hypersensitivity reactions, including anaphylaxis/anaphylactoid reactions, and should monitor their patients accordingly.
• Appropriate procedures should be followed to treat anaphylaxis/anaphylactoid reactions if necessary.
• MACUGEN is currently contraindicated in patients with a known hypersensitivity to any component of this preparation.

MACUGEN is indicated for the treatment of subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration, and is administered once every six weeks by intravitreous injection. Since market introduction in the United States in January 2005, there have been rare post-marketing spontaneous reports of hypersensitivity reactions, including anaphylaxis/anaphylactoid reactions and angioedema, observed within several hours following the MACUGEN intravitreal administration procedure. There were no reports of anaphylaxis attributed to the use of MACUGEN in clinical trials. Since the aseptic injection preparation procedure consists of various components (e.g., adequate anesthesia, broad-spectrum microbicide, possibly latex gloves), a direct relationship to MACUGEN or other factors has not been established in these cases. The patient's medical history of hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal injection procedure.

We are currently working with Health Canada to update the MACUGEN Product Monograph to reflect this recent post-marketing experience. Pfizer Canada's website (www.pfizer.ca) will be updated once the final Product Monograph becomes available.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments.

Any occurrence of hypersensitivity reactions including anaphylaxis/anaphylactoid reactions and angioedema or other serious or unexpected adverse reactions in patients receiving MACUGEN should be reported to Pfizer Canada Inc. or Health Canada at the following addresses:

Pfizer Canada Inc.

Drug Safety

P.O. Box 800

Pointe-Claire- Dorval, Quebec

H9R 4V2

Tel: 1-800-463-6001 (Medical Information)

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.

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

Should you have any questions or require additional information, please contact Pfizer Canada Inc. at 1-800-463-6001 from 8:00 AM to 5: 00 PM Monday to Friday Eastern Standard Time.

Sincerely,

original signed by

Dr. Bernard Prigent

Vice-President and Medical Director

Medical Division

* TM Eyetech Pharmaceuticals Inc., Pfizer Canada Inc., licensee