Health Canada Fluoroquinolone Warning Notes Peripheral Neuropathy, Other Disabling Side Effects

Published on January 26, 2017 by Sandy Liebhard

Health Canada has issued an  alert warning consumers in that country about debilitating side effects potentially associated with fluoroquinolone antibiotics, including peripheral neuropathy. The regulator is working with the drugs’  manufacturers to update the safety information of all systemic (taken by mouth or by injection) fluoroquinolone products marketed in Canada.

Fluoroquinolones are indicated to treat many types of bacterial infections including urinary tract and respiratory infections.  Drugs in this class that have been approved for sale in Canada include:

  • Ciprofloxacin (Cipro)
  • Levofloxacin (Levaquin)
  • Moxifloxacin (Avelox)
  • Norfloxacin
  • Ofloxacin

Each year in Canada, roughly 3.1 million prescriptions are filled for fluoroquinolones. The majority of these (98%) are filled for adults.

Health Canada Review

Health Canada launched a review of the drug class after a similar investigation by the U.S. Food & Drug Administration (FDA) confirmed that that the antibiotics could cause persistent (lasting 30 days or longer after stopping use of fluoroquinolones) and disabling side effects.  The U.S. labels have since been updated with a Black Box Warning stating that the risks associated with fluoroquinolones generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections when alternative treatment options are available.

The Health Canada investigation focused on the following fluoroquinolone-related complications:

  • Tendonitis/tendinopathy
  • Peripheral neuropathy
  • Worsening of myasthenia gravis
  • Hypersensitivity and serious skin reaction
  • Mental disorders
  • Depression and suicide/self-injury
  • Convulsions (seizure)
  • Cardiovascular disorders
  • Phototoxicity (light sensitivity)
  • Vision disorders

The Health Canada review identified 115 reports of persistent and disabling side effects associated with the use of fluoroquinolones. In 78 of these reports, a causal link was established. In the remaining cases, there was either not enough information available or it was unlikely that the issues were related to the use of fluoroquinolones. The majority of the reports involved tendon injuries, peripheral neuropathy and central nervous system disorders. While these complications are noted on the current fluoroquinolone labeling, Health Canada said the possibility of persistent duration is not included.

U.S. Fluoroquinolone Litigation

Levaquin, Cipro and Avelox are currently the subject of hundreds of U.S. lawsuits filed on behalf of patients who developed peripheral neuropathy allegedly related to use of of the drugs. The majority of these claims have been centralized in a federal litigation underway in the U.S. District Court, District of Minnesota. Other recent filings have involved  accusations that the medications can cause serious aortic injuries, including aortic dissection and aortic aneurysm.

Get the latest news and litigation updates about this case by following us on Facebook. Click the "Like" button below.


Follow Us on Google+ on Facebook on LinkedIn on Twitter on YouTube on Pinterest

Skip to content