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ADR that result in revision of patient information

 
Canada: FLUOROQUINOLONES - Risk of disabling and persistent serious adverse reactions
 
Health Canada advised that Canadian and international cases of disabling and persistent serious adverse reactions including tendinopathy, peripheral neuropathy, and central nervous system disorders have been reported in patients treated with oral and injectable fluoroquinolones. These included FLUOROQUINOLONES (ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin), in oral and injectable dosage forms.

Fluoroquinolones are a class of antibacterial drugs used in the treatment of various gram-negative and gram-positive bacterial infections, including respiratory and urinary tract infections.

Health Canada conducted an assessment to examine the safety of systemic fluoroquinolones. This was prompted by the findings of the United States Food and Drug Administration benefit/risk assessment on systemic fluoroquinolones and the occurrence of disabling and persistent adverse reactions.

Health Canada’s safety review focused on already known and labelled adverse reactions associated with the use of fluoroquinolones that resulted in persistent disability. Health Canada has received reports of a small number of these cases over time. The reported adverse reactions in Canada associated with persistent disability mostly involved the musculoskeletal system (e.g., tendonitis and Achilles tendon rupture), peripheral neuropathy and central nervous system disorders (e.g., depression, anxiety, dizziness and confusion).

Health Canada’s assessment concluded that fluoroquinolones are associated with rare cases of disabling and persistent serious adverse reactions such as tendinopathy, peripheral neuropathy, and central nervous system disorders. Health Canada consulted the Scientific Advisory Panel on Anti-Infective Therapies (SAP-AIT) on the use of fluoroquinolones for treating certain infections, considering their potential association with disabling and persistent events. The SAP-AIT recommended labelling updates to all systemic fluoroquinolones to include information on the severity and persistence of these adverse reactions.

Consumers are advised that fluoroquinolones are generally well tolerated but they have been associated with rare serious side effects that were disabling and persistent, including tendon damage, nerve damage in the hands and feet, and central nervous system disorders. These side effects can occur hours to weeks after exposure to fluoroquinolone treatment. Patients should inform their healthcare professional if they think they have previously experienced a side effect related to fluoroquinolone use. Patients should immediately consult a healthcare professional if they experience serious side effects, such as joint and muscle pain, swelling or rupture of a tendon, tingling, numbness, weakness, or other alterations of sensation, tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, suicidal thoughts.

Health Canada advised healthcare professionals of the following:
• It is recommended that the potential for disabling and persistent serious adverse events be considered when choosing to prescribe a fluoroquinolone.
• Fluoroquinolones should not be prescribed to patients who have experienced serious adverse reactions during or after prior treatments.
• Stop systemic fluoroquinolone treatment if a patient reports a serious adverse reaction. The patient’s treatment should be switched to an alternative treatment with a non-fluoroquinolone antibacterial drug if needed to complete the treatment course.
• Some adverse reactions associated with the use of fluoroquinolones can occur within hours to weeks after exposure to the treatment.

Please refer to the following website in Health Canada for details: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../61900a-eng.php

In Hong Kong, there are 250 registered pharmaceutical products containing fluoroquinolones, including 106 ciprofloxacin, 67 levofloxacin, 54 ofloxacin, 8 moxifloxacin, 11 norfloxacin, 2 lomefloxacin, 1 prulifloxacin and 1 sparfloxacin products. All these products are prescription only medicines.

Related news was previously issued by the US FDA, and was posted on the Drug Office website on peripheral neuropathy on 16 August 2013, on disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system on 13 May 2016 and 27 July 2016. Letters to inform local healthcare professionals were issued on 16 August 2013 and 13 May 2016. In December 2013, the Registration Committee of the Pharmacy and Poisons Board (the Registration Committee) discussed the matters on peripheral neuropathy with fluoroquinolones, and decided that the relevant warnings should be included in the sales packs and/or package inserts of the products. In September 2016, the Registration Committee further discussed the matters on disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system with fluoroquinolones, and subsequently decided to remain vigilant on any updates by other overseas drug regulatory authorities.

So far, the Department of Health has received two cases of adverse drug reaction (ADR) with levofloxacin, which were not related to the adverse effects mentioned in the above Health Canada announcement, and no ADR report has been received for the remaining fluoroquinolones. In view of the above Health Canada announcement, the matter will be further discussed by the Registration Committee.


Ends/ Tuesday, January 24, 2017
Issued at HKT 15:00
 
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The United States: FDA Drug Safety Communication: FDA updates warnings for oral ... Posted 2016-07-27
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