Pulmicort Turbuhaler (budesonide) powder for oral inhalation - Potential device failure - For Health Professionals

Starting date:

July 23, 2012

Posting date:

July 26, 2012

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-15087

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

Health Canada Endorsed Important Safety Information on PULMICORT TURBUHALER (budesonide) powder for oral inhalation, 200 µg per metered dose

July 23, 2012

Dear Health Care Professional:

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 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) regarding the malfunction of the delivery device that results in a failure to dispense the dose of medication.  The cause of these complaints is related to an issue within the dosing unit.  The patient will not hear the 'click' sound when the 'turn grip' is rotated, and the intended dose of medication will not be loaded into the unit.  Patients who do not realize that the dose has not been loaded may go for a period of time without receiving the prescribed treatment.

• Complaints for PULMICORT TURBUHALER, 200 µg per metered dose (200 doses) have been received regarding the malfunction of the delivery device in which the patient does not hear the 'click' sound, indicating that the intended dose is not loaded into the unit, resulting in failure to dispense medication.
• It is important to discuss and reinforce the proper use of the PULMICORT TURBUHALER device with patients (TURN, CLICK, INHALE), as described 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.
• If a patient believes that their PULMICORT TURBUHALER is not working properly, they should contact their health care professional. Additionally, they could contact AstraZeneca Medical Information at 1-800-668-6000 (English) and/or 1-800-461-3787 (French).

PULMICORT TURBUHALER is a glucocorticosteroid for the treatment of bronchial asthma in patients who require inhaled steroids, and in patients for whom a reduction of systemic glucocorticoids is desirable.  TURBUHALER is a multi-dose, dry powder inhaler. AstraZeneca is further investigating the incidents and will continue to monitor for any additional 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 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 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 correct your mailing address or fax number, contact AstraZeneca Canada Inc.

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. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.

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, please do not hesitate 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.