Information Update - Fluoroquinolone antibiotics may, in rare cases, cause persistent disabling side effects

Starting date:

January 23, 2017

Posting date:

January 23, 2017

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

New safety information

Audience:

General Public

Identification number:

RA-61920

• Issue
• What you should do
• What industry professionals should do
• Report health or safety concerns
• Related AWRs
• Media enquiries
• Public enquiries

Issue

OTTAWA – Health Canada’s recent safety review of oral and injectable fluoroquinolones, a class of antibiotics, found that in rare cases some known side effects may be persistent or disabling. This includes muscular issues such as tendonitis and Achilles tendon rupture, nerve damage such as peripheral neuropathy, and central nervous system issues such as anxiety, dizziness and confusion.

As a result of its safety review, Health Canada is working with manufacturers to include information concerning this rare but serious risk in the product labelling of these drugs.

Fluoroquinolone antibiotics are used to treat several types of infections, including respiratory and urinary tract infections. Reactions can occur hours to weeks after taking a fluoroquinolone.

There are several oral and injectable fluoroquinolones available in Canada, both generic and brand name:

• ciprofloxacin (Cipro);
• moxifloxacin (Avelox);
• levofloxacin;
• norfloxacin; and
• ofloxacin.

Health Canada is also working with the Drug Safety and Effectiveness Network and the Canadian Agency for Drugs and Technologies in Health to conduct additional studies to better understand the use of fluoroquinolones in Canada.

If new safety information is identified, Canadians will be updated, as required.

What you should do

• Before taking a fluoroquinolone antibiotic, tell your healthcare professional if you have previously experienced a side effect related to fluoroquinolone use.
• Consult a healthcare professional if you experience side effects such as joint and muscle pain, numbness, tingling or confusion while taking a fluoroquinolone.
• Discuss any questions or concerns you may have about your fluoroquinolone treatment with your healthcare professional.

What industry professionals should do

• 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 previously experienced serious adverse reactions to fluoroquinolones.
• Stop a fluoroquinolone treatment if a patient reports a serious adverse reaction and substitute with a non-fluoroquinolone antibacterial drug, if required, to complete the patient’s treatment course.

Report health or safety concerns

To report a side effect to a health product to Health Canada:

• Call toll-free at 1-866-234-2345
• Visit Health Canada’s Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Related AWRs

FLUOROQUINOLONES - Risk of Disabling and Persistent Serious Adverse Reactions

2017-01-23 | Health products

Advisory

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709