Health Canada: Fluoroquinolone safety information update

Fluoroquinolones:

Fluoroquinolones are a class of prescription antibiotic, approved for use in Canada to treat many types of bacterial infections, including respiratory and urinary tract infections. They include: ciprofloxacin (Cipro), moxifloxacin (Avelox), levofloxacin, norfloxacin and ofloxacin.

Current labeling includes a warning that the drugs can lead to tendon ruptures.

Health Canada Review:

Health Canada reviewed the potential risk of side effects from the use of oral or injected fluoroquinolones, focusing on the more serious known side effects:

• Tendonitis/tendinopathy (tendon inflammation)
• Peripheral nerve damage
• Worsening of myasthenia gravis (a chronic autoimmune disease)
• Serious skin reactions
• Mental disorders, depression and suicide/self-injury, seizures
• Cardiovascular disorders
• Phototoxicity (light sensitivity) and vision disorders

Findings:

Health Canada concluded that these side effects can be “persistent and disabling in rare cases.”

This is based on 29 probable (or 49 possible) reported cases of persistent and serious side effects that could be causally linked to fluoroquinolone use. There are about 3.1 million prescriptions for fluoroquinolone filled each year in Canada.

Next steps:

Health Canada is working with the manufacturers to update the safety information on fluoroquinolones to include this “rare but serious risk.”

Researchers will conduct research to better understand the use of fluoroquinolones in Canada.

Health Canada recommends that you inform your healthcare provider if you experience numbness, joint or muscle pain, hypersensitivity or confusion, while taking fluoroquinolones.

Before taking a fluoroquinolone, inform your doctor if you have experienced any of these symptoms in the past, related to its use.

Read the full Health Canada review summary

The CBC website also has an article about the warning