FLUOROQUINOLONES - Risk of Disabling and Persistent Serious Adverse Reactions

Starting date:
January 23, 2017
Posting date:
January 23, 2017
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals, General Public
Identification number:
RA-61900

Audience

Healthcare professionals

Key messages

  • Rare cases of disabling and persistent serious adverse reactions including tendinopathy, peripheral neuropathy, and central nervous system disorders have been reported to Health Canada for fluoroquinolones when used systemically (i.e. taken by mouth or by injection).
  • Healthcare professionals are reminded to:
    • Consider the potential for disabling and persistent serious adverse events when choosing to prescribe a fluoroquinolone. 
    • Avoid fluoroquinolones in patients who have previously experienced serious adverse reactions associated with them.
    • Stop fluoroquinolone treatment if a patient reports any serious adverse reaction. Patients should be switched to an alternative treatment with a non-fluoroquinolone antibacterial drug, if needed, to complete the treatment course.
  • Health Canada is currently working with manufacturers to strengthen the prescribing information for these drugs.

      

Issue

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.

Products affected

FLUOROQUINOLONES (ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin), oral and injectable dosage forms.

Background information

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.

Who is affected

Information for consumers

Fluoroquinolones are a class of prescription antibacterial drugs that are used to treat several types of bacterial infections.

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.

Information for healthcare professionals

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. 

Healthcare professionals are advised to 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.

Healthcare professionals should be aware that some adverse reactions associated with the use of fluoroquinolones can occur within hours to weeks after exposure to the treatment.

Action taken by Health Canada

Health Canada is working with the manufacturers to update the fluoroquinolone Canadian Product Monographs. Health Canada continues to monitor the situation and will take further action as deemed necessary.

Health Canada is communicating this important safety information update to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication update will be further distributed through the MedEffect™ e-Notice email notification system.

Report health or safety concerns

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious or unexpected side effects in patients receiving fluoroquinolones should be reported to Health Canada.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:

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