Updated Labelling for Antibiotic Avelox (Moxifloxacin) Regarding Rare Risk of Severe Liver Injury

Starting date:

March 22, 2010

Posting date:

March 22, 2010

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product label update, Product Safety

Audience:

General Public

Identification number:

RA-110004138

• 
  Media enquiries
• 
  Public enquiries

Health Canada is informing health care professionals and Canadians of changes to the labelling information for the prescription antibiotic Avelox (moxifloxacin). The updated labelling incorporates important safety information related to the rare risk of severe liver injury.

Avelox belongs to a family of antibiotic drugs known as quinolones and is used to treat a broad range of bacterial infections, including respiratory infections. It can be taken by mouth in a tablet format, or administered by injection. Health Canada has conducted a safety review and concluded that Avelox may be associated with the rare but potentially life threatening risk of liver injury, including liver failure.

Symptoms of liver problems include abdominal pain, loss of appetite, yellowing of the skin and eyes, severe itching, dark urine, and pale-coloured stools. Patients who experience any of these symptoms are advised to stop taking Avelox and contact a health care professional immediately.

This information has been incorporated into the Warnings and Precautions section, and also in the Consumer Information section of the product monograph for Avelox.

Patients are invited to read the Consumer Information section of the Canadian Product Monograph to familiarize themselves with the safety information for this antibiotic. Patients with questions or concerns regarding the use of Avelox should talk to their pharmacist or physician.

Consumers requiring more information about this information update can contact Health Canada’s public enquiries line at 613-957-2991, or toll free at 1-866-225-0709.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at the MedEffect™ Canada section of the Health Canada website
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting Form and either:
  • Fax toll-free to 1-866-678-6789
  • Mail to: Canada Vigilance Program
    
    Health Canada
    
    AL 0701D
    
    Ottawa, ON K1A 0K9

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the Health Canada website. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this section.

 

Product Monograph for Avelox

The product monograph for Avelox is available in Health Canada's Drug Product Database (DPD). Select the link "Drug Product Database Online Query" on the Drug Product Database page and then continue with a search for the product name "Avelox".

 

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709