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Fluoroquinolone Antibiotics (AVELOX, CIPRO, CIPRO XL, and LEVAQUIN) - Worsening of Symptoms in Patients with Myasthenia Gravis - For Health Professionals
- Starting date:
- March 9, 2012
- Posting date:
- March 9, 2012
- Type of communication:
- Dear Healthcare Professional Letter
- Source of recall:
- Health Canada
- Healthcare Professionals
- Identification number:
This is duplicated text of a letter from Bayer Inc. and Janssen Inc.
Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on Fluoroquinolone antibiotics (AVELOX, CIPRO, CIPRO-XL, and LEVAQUIN)
March 9, 2012
Dear Health Care Professional,
Subject: Association of fluoroquinolone antibiotics (AVELOX®, CIPRO®, CIPRO® XL, and LEVAQUIN®) with worsening of symptoms of myasthenia gravis in patients with myasthenia gravis
The manufacturers of the fluoroquinolone innovator products (Bayer Inc. and Janssen Inc.) in consultation with Health Canada would like to inform you of important updates to the labelling for fluoroquinolone antibiotics (AVELOX®, CIPRO®, CIPRO® XL, and LEVAQUIN®).
Fluoroquinolone antibiotics are indicated for the treatment of adults with various bacterial infections caused by susceptible strains of bacteria, such as respiratory tract infections, skin infections and urinary tract infections.
Health professionals should be aware that the Canadian Product Monographs (PM) for all the innovator fluoroquinolone antibiotics were updated by January 2012 to reflect the potential for the exacerbation of myasthenia gravis symptoms in patients with myasthenia gravis.
- Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis.
- Exacerbation of myasthenia gravis symptoms in patients with myasthenia gravis can lead to a requirement for respiratory support in some patients.
- Fluoroquinolone antibiotics should be avoided in patients with a known history of myasthenia gravis.
The association between the exacerbation of myasthenia gravis and fluoroquinolone use has been established based on the review of post-marketing reports. Cases of serious adverse events, including deaths and requirement for ventilatory support have been associated with fluoroquinolone use in patients with myasthenia gravis.
Exacerbation of symptoms of myasthenia gravis was already included as an undesirable effect in earlier versions of the Product Monographs of Avelox®, Cipro®, Cipro® XL and LEVAQUIN®. To reinforce the warning, the Product Monographs for the innovator fluoroquinolone antibiotics have been revised under the Warnings and Precautions section to include information that they may exacerbate muscle weakness in patients with myasthenia gravis. The corresponding generic Product Monographs are in the process of being updated to reflect these warnings.
Managing marketed health product-related adverse reactions depends on healthcare 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 adverse reactions related to exacerbation of symptoms of myasthenia gravis in patients with myasthenia gravis or other serious or unexpected adverse reactions in patients receiving fluoroquinolone antibiotics should be reported to Bayer Inc., Janssen Inc. or Health Canada.
For AVELOX®, CIPRO® and CIPRO® XL:
77 Belfield Road
Toll-free telephone: 1-800-265-7382
19 Green Belt Drive
Toll-free telephone: 1-866-825-7122
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at MedEffect™ Canada
- Call toll-free at 1-866-234-2345
Complete a Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program
Postal Locator 0701E
Ottawa, Ontario K1A 0K9
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:
Marketed Health Products Directorate
To change your mailing address or fax number, contact the Market Authorization Holder (Industry).
original signed by
Shurjeel Choudhri, MD FRCPC
Senior Vice President & Head,
Medical & Scientific Affairs
Bayer HealthCare Pharmaceuticals
Cathy Lau, PhD.
Regulatory and Quality
- AVELOX Product Monograph, January 20, 2012.
- CIPRO Product Monograph, January 23, 2012.
- CIPRO XL Product Monograph, January 23, 2012.
- LEVAQUIN Product Monograph, February 24, 2012.
- Date modified: