Pulmicort Turbuhaler (budesonide) powder for oral inhalation - Potential device failure - For the Public

Starting date:

July 23, 2012

Posting date:

July 26, 2012

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-14800

This is duplicated text of a letter from AstraZeneca Canada Inc. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication - Health Canada Endorsed Important Safety Information on Pulmicort Turbuhaler (budesonide) powder for oral inhalation, 200 µg per metered dose

July 23, 2012

Subject: Potential device failure related to Pulmicort^® Turbuhaler^® (budesonide) powder for oral inhalation, 200 µg per metered dose (200 doses; DIN 00851752)

AstraZeneca Canada Inc., in consultation with Health Canada, would like to inform you of important information regarding complaints related to the asthma medication, Pulmicort^® Turbuhaler^® (budesonide) powder for oral inhalation, 200 µg per metered dose (200 doses). AstraZeneca Canada has received a small number of product complaints for Pulmicort Turbuhaler, 200 µg per metered dose (200 doses) related to the delivery device not working properly. Patients are advised that if they do not hear the 'click' sound when the 'turn grip' is rotated, the device is not working properly and they will not receive the dose of medication.

• Complaints for Pulmicort Turbuhaler, 200 µg per metered dose (200 doses) have been received about the delivery device not working properly. Patients are advised that if they do not hear the "click" sound, the device is not working properly and they will not receive the dose of medication.
• If a patient believes that their Pulmicort Turbuhaler is not working properly, they should contact their dispensing pharmacist or other health care professional. Additionally, they may contact AstraZeneca Medical Information at 1-800-668-6000 (English) and/or 1-800-461-3787 (French).
• It is important for patients to understand the proper use of Pulmicort Turbuhaler (Turn, Click, Inhale), as described in the Consumer Information Leaflet.
• In the Consumer Information Leaflet, patients are instructed to listen for the 'click' sound, as an indication that the inhaler has been loaded and is ready to use. A copy of the Consumer Information Leaflet can be found at: http://www.astrazeneca.ca/en/Our-Medicines/en-Products-AZ.

Pulmicort Turbuhaler is the brand name for the inhaled form of a drug called budesonide. Budesonide belongs to a group of medicines called corticosteroids which are used to reduce airway inflammation in patients with asthma. Turbuhaler is the brand name for a multiple-dose, dry powder inhaler. AstraZeneca is working to further investigate the complaints. This issue is specific to Pulmicort Turbuhaler, 200 µg per metered dose (200 doses).

Managing marketed health product-related adverse reactions depends on health care professionals and patients reporting them to the company or Health Canada. Therefore, the number of adverse reactions reported is generally believed to be less than those that actually occur. Any case of adverse reactions in patients receiving Pulmicort Turbuhaler should be reported to AstraZeneca Canada or Health Canada at the following addresses:

AstraZeneca Canada Inc.

1004 Middlegate Road

Mississauga, Ontario

Canada L4Y 1M4

Telephone: 1-877-404-8277

To report suspected adverse reactions to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or visit the MedEffect™ Canada Web site for information on how to report.

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section.

For other health product inquiries related to this communication, please contact Health Canada at:

Health Products and Food Branch Inspectorate (HPFBI)

E-mail: DCVIU_UVECM@hc-sc.gc.ca

Telephone: 1-800-267-9675

Fax: 1-613-946-5636

Should you have any medical questions about Pulmicort Turbuhaler, feel free to contact AstraZeneca Medical Information at 1-800-668-6000 (English) and/or 1-800-461-3787 (French).

original signed by

Dr. Neil Maresky, M.B., B.Ch.

Vice President, Scientific Affairs

AstraZeneca Canada Inc.

Pulmicort^®, Turbuhaler^®, and the AstraZeneca logo are registered trademarks of the AstraZeneca group of companies.