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Market withdrawal of Raptiva (efalizumab) in Canada- For the Public

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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 EMD Serono Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

Public Communication
Health Canada Endorsed Important Safety Information on Raptiva (efalizumab)

June 11, 2009

Subject: Communication on the decision to withdraw Raptiva^® in Canada

This Communication is to inform you about the decision for EMD Serono Canada Inc. to withdraw the market authorization of RAPTIVA in Canada.

EMD Serono Canada Inc., the company that markets RAPTIVA in Canada has in consultation with Health Canada decided to terminate the marketing of Raptiva (efalizumab) in Canada, due to safety concerns.

RAPTIVA was authorized in October 2005 for the treatment of plaque psoriasis in adult patients.

Summary:

• Effective June 8, 2009, Raptiva will no longer be available on the Canadian market, and all markets globally.
• The marketing of Raptiva in Canada was suspended on February 20, 2009 following the determination that the benefit of Raptiva in psoriasis patients was outweighed by the risk of developing a serious and potentially fatal brain infection. A public communication (PC) was issued in regard to the suspension of marketing of this product, at that time.
• Health care providers in Canada were notified to switch their patients to other available alternative therapies, as Raptiva would no longer be available after 3 months.
• All patients have now had more then 3 months to review their treatment with their health care providers and to switch to alternative psoriasis treatments.
• Patients previously taking Raptiva, who develop any serious and/or unexpected adverse reactions should report these to a health care provider and mention that they had been previously treated with Raptiva.

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 occurrence of serious and/or unexpected adverse reactions in patients who received RAPTIVA should be reported to EMD Serono Canada Inc., or Health Canada at the following addresses:

Should you have any questions regarding the withdrawal of RAPTIVA, please call EMD Serono Canada Inc.’s Patient Services at 1-866-440-4245.

original signed by

Peter Grosser, Ph.D.
Director, Regulatory Affairs, Drug Safety & Medical Information
EMD Serono Canada Inc.