"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," the Canadian health authority—the equivalent to the US Food and Drug Administration—said in a statement released March 22.
An earlier safety review by the European Medicines Agency prompted Health Canada to conduct its own safety review of moxifloxacin, which is an antibiotic within the quinolone family.
The review also found that while the potential for liver-related side effects was well documented on the Canadian product label, Health Canada determined that there needed to be a better job done with regard to communicating that information to patients in a real and effective way.
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However, the potentially rare risk to proper liver function is not well known. It is also a sad truth that most patients do not read product labels or medication guides, leaving it to their doctor to sort all that out on the patient's behalf.
Some doctors do not adequately inform their patients as to the possibility or potential severity of Avelox adverse reactions.
Health Canada advised patients experiencing symptoms ranging from loss of appetite and abdominal pain, to dark urine and yellowing of the skin or eyes, "to stop taking Avelox and contact a health-care professional immediately."
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