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

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-15856

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.

Notice about Health Canada advisories

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.

This information has been summarized for patients in a related Public Communication that can be accessed on the Web Sites of Health Canada, Bayer Inc. and Janssen Inc.

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:
Bayer Inc.
77 Belfield Road
Toronto, Ontario
M9W 1G6
Toll-free telephone: 1-800-265-7382
E-mail: Canada.medinfo@bayer.com

For LEVAQUIN^®:
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
Toll-free telephone: 1-866-825-7122
E-mail: dsscan@joica.jnj.com
Fax: 1-866-767-5865

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
    Health Canada
    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
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

To change your mailing address or fax number, contact the Market Authorization Holder (Industry).

Sincerely,

original signed by

Shurjeel Choudhri, MD FRCPC
Senior Vice President & Head,
Medical & Scientific Affairs
Bayer HealthCare Pharmaceuticals

Cathy Lau, PhD.
Vice President,
Regulatory and Quality
Janssen Inc.

References:

1. AVELOX Product Monograph, January 20, 2012.
2. CIPRO Product Monograph, January 23, 2012.
3. CIPRO XL Product Monograph, January 23, 2012.
4. LEVAQUIN Product Monograph, February 24, 2012.