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

Mon, 03/22/2010 - 7:22am
Health Canada

OTTAWA - 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:

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".

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Media Enquiries:

Health Canada

(613) 957-2983

Public Enquiries:

(613) 957-2991

1-866 225-0709

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