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Association of Relenza (zanamivir) Dry Powder for Inhalation with Fatal Outcome when Administered by Nebulization Instead of Inhalation - Notice to Hospitals
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(PDF Version - 27 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 GlaxoSmithKline Inc.
Contact the company for a copy of any references, attachments or enclosures.
NOTICE TO HOSPITALS
Health Canada Endorsed Important Safety Information on Relenza (zanamivir) Dry Powder for Inhalation
November 3, 2009
To: Hospital Chief of Medical Staff, Chief of Pharmacy
Please distribute to relevant Departments of Pharmacy, Surgery, Anaesthesia, Intensive Care, Paediatrics, Emergency Medicine, Internal Medicine (including infectious diseases and respiratory), and/or other Departments as required, and other involved professional staff and post this NOTICE in your institution.
Subject: Association of RELENZA® (zanamivir) Dry Powder for Inhalation with fatal outcome when administered by nebulization, an unapproved use.
GlaxoSmithKline (GSK) is aware that RELENZA® Dry Powder for Inhalation is being removed from its original and approved packaging and dissolved in various solutions for the purpose of nebulizing zanamivir and treat patients who are unable to take oral medications or to inhale RELENZA® Dry Powder for Inhalation using the Diskhaler® inhalation device. GSK has received a report of the death of a patient treated for influenza infection with RELENZA® (zanamivir) Dry Powder for Inhalation which was solubilized and administered by nebulization and through mechanical ventilation.
Healthcare Providers should note the following information regarding the use of RELENZA®:
- RELENZA® (zanamivir) Dry Powder for Inhalation is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator.
- RELENZA® or zanamivir for nebulization has not been approved by any regulatory authority and the safety, effectiveness and stability of zanamivir use by nebulization have not been established.
The death referenced above was of a pregnant woman on mechanical ventilation who received zanamivir solution made from dry powder product from RELENZA® Rotadisks® via nebulizer for three days. Death was attributed to obstruction of the ventilator. The reporting physician believed that lactose (from RELENZA® Dry Powder for Inhalation) combined with the nebulizing solution (used to dissolve the powder) caused the obstruction. As of October 9, 2009 there have been no reports of adverse events related to such use in Canada.
RELENZA® Dry Powder for Inhalation should only be used as directed in the Product Monograph by using the Diskhaler® device provided with the drug product. RELENZA® Dry Powder for Inhalation is a mixture of zanamivir active drug substance (5 mg) and lactose drug carrier (20 mg). This formulation is not designed or intended to be administered by nebulization. There is risk that the lactose sugar in this formulation can obstruct proper functioning of mechanical ventilator equipment.
RELENZA® (zanamivir) is a neuraminidase inhibitor indicated for treatment of uncomplicated illness due to influenza A and B in patients 7 years of age or older who have been symptomatic for no more than 2 days. RELENZA® is also indicated for prophylaxis of influenza in patients 7 years of age or older.
For detailed information on Indications and Clinical Use, Contraindications, Warnings and Precautions, and Adverse Reactions, please consult the Product Monograph for RELENZA® (zanamivir) Dry Powder for Inhalation available on the 
GlaxoSmithKline Inc. Web site or on the Health Canada Web site.
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 case of serious or unexpected adverse reactions in patients receiving RELENZA® Dry Powder for Inhalation should be reported to GlaxoSmithKline or Health Canada at the following addresses:
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Tel.: 1-800-387-7374
www.gsk.caAny suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701D
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: 866-234-2345
Fax: 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
Sincerely,
original signed by
Dr. Tjark Reblin, MD, MBA
Vice President, Medical Division and Chief Medical Officer
GlaxoSmithKline Inc.
®RELENZA, DISKHALER and ROTADISK are registered trademarks, used under license by GlaxoSmithKline Inc.
