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Market withdrawal of Raptiva (efalizumab) in Canada - For Health Professionals
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(PDF Version - 54 K)Contact: Marketed Health Products Directorate (MHPD)
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This is duplicated text of a letter from EMD Serono Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on Raptiva (efalizumab)
June 11, 2009
Dear Health Care Professional,
This Communication is to inform you that EMD Serono Canada Inc. has formally withdrawn the market authorization of RAPTIVA in Canada as of June 8, 2009.
EMD Serono Canada Inc., the company that markets RAPTIVA in Canada has decided, in consultation, with Health Canada, to terminate marketing of Raptiva (efalizumab) in Canada, due to safety concerns.
RAPTIVA is an immunomodulating, humanized monoclonal antibody which was authorized in Canada in 2005 for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
- Effective June 8, 2009, Raptiva will no longer be available on the Canadian market, from all or any markets, globally.
- The marketing authorization of Raptiva, in Canada, was suspended on February 20, 2009 following the determination by the European Medicines Agency that the benefit/risk balance in its approved indication was no longer favourable, due to safety concerns related to the risk of progressive multifocal leukoencephalopathy (PML). A health care professional (HPC) and public communications (PC) were issued in regard to the suspension of marketing of this product, at that time.
- Prescribers in Canada were notified on February 20, 2009 not to issue any new prescriptions for RAPTIVA and to switch patients to alternative therapies. Pharmacists were also notified on February 24, 2009 not to fill any new prescriptions.
- Prescribers have now had more than 3 months to review the treatment of all patients taking Raptiva and switch them to alternative psoriasis treatments.
- EMD Serono Canada Inc., notified pharmacies and distribution centres on May 14, 2009 to return all remaining product. Supplies of Raptiva were quarantined on March 11, 2009 and no product has been shipped out since that date.
- Prescribers and other health care providers should continue to monitor carefully all patients that were taking Raptiva, for any signs or symptoms suggestive of PML, and/or other adverse effects.
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:
2695 North Sheridan Way, Suite 200
Mississauga ON L5K 2N6
Telephone: 1-888-737-6668 ext. 5160
Fax: 905-919-0292
E-mail: drugsafetycanada@merckserono.net
Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 1-866-234-2345
Fax: 1-866-678-6789
CanadaVigilance@hc-sc.gc.ca
The Adverse Reaction Reporting Form and the Adverse Reaction 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
Telephone: 613-954-6522
Fax: 613-952-7738
Should you have any questions regarding the withdrawal of RAPTIVA, please call the EMD Serono Medical Information/Drug Safety Department at 1-888-737-6668 x 5160.
original signed by
Peter Grosser, Ph.D.
Director, Regulatory Affairs, Drug Safety & Medical Information
EMD Serono Canada Inc.
