Summary Safety Review - Fluoroquinolones - Assessing the potential risk of persistent and disabling side effects

January 23, 2017

Product

Fluoroquinolones (Ciprofloxacin, Levofloxacin, Moxifloxacin, Norfloxacin and Ofloxacin)

Potential Safety Issue

Persistent (prolonged) and disabling side effects including tendonitis/tendinopathy (tendon inflammation or disorder), peripheral neuropathy (damage to or disorder affecting the nerves outside the spinal cord and brain) and central nervous system disorders (related to disorders of the brain).

Key Messages

  • Fluoroquinolones are antibacterial (antibiotics) prescription drugs which are authorized for sale in Canada to treat many types of bacterial infections including urinary tract and respiratory infections.
  • Health Canada carried out a review of the potential risk of persistent and disabling side effects linked to the use of fluoroquinolones. The review was triggered by a benefit and safety review done by the United States Food and Drug Administration (FDA) on systemic (taken by mouth or by injection) fluoroquinolone drugs.
  • Health Canada's review concluded that some of the known side effects (tendonitis/tendinopathy, peripheral neuropathy and central nervous system disorders) linked to the use of fluoroquinolones may be persistent and disablingFootnote a in rare cases. Health Canada is working with the manufacturers to update the safety information for all fluoroquinolones to inform about this potential risk.

Overview

Health Canada started a safety review following a review done by the FDA on systemic (taken by mouth or by injection) fluoroquinolone drugs. The FDA review showed that there were persistent (lasting 30 days or longer after stopping use of fluoroquinolones) and disabling side effects linked to the use of fluoroquinolone products. The Health Canada safety review focussed on serious known side effects that included: tendonitis/tendinopathy (tendon inflammation), peripheral neuropathy (damage to or disorder affecting the nerves), worsening of myasthenia gravis (a chronic autoimmune disease), hypersensitivity and serious skin reactions, mental disorders, depression and suicide/self-injury, convulsions (seizure), cardiovascular disorders, phototoxicity (light sensitivity) and vision disorders.

Use in Canada

  • Fluoroquinolones (taken by mouth or by injection) are authorized for sale in Canada for the treatment of many types of bacterial infections, including urinary and respiratory tract infections.
  • Fluoroquinolones have been marketed in Canada since 1986. There are several oral and injectable fluoroquinolones available in Canada, as generics and brand names:
    • ciprofloxacin (Cipro),
    • moxifloxacin (Avelox),
    • levofloxacin,
    • norfloxacin,
    • ofloxacin.
  • Each year in Canada, there are around 3.1 million prescriptions filled for fluoroquinolones - most of them are for adults (98%).

Safety Review Findings

  • At the time of the review, Health Canada identified 115 reportsFootnote of persistent and disabling side effects associated with the use of fluoroquinolones. In 78 of these reports, a probable (29 reports) or possible (49 reports) causal link could be made between the use of fluoroquinolones and persistent disability. In the remaining cases, there was either not enough information available or it was unlikely that the reports of persistent disability were related to the use of fluoroquinolones.
  • Most of the side effects that were reported in the 115 reports and were linked to persistent disability included tendonitis/tendinopathy (tendon inflammation or disorder), peripheral neuropathy (damage to or disorder affecting the nerves outside the spinal cord and brain) and central nervous system disorders (related to disorders of the brain). The side effects of tendinopathy, peripheral neuropathy and central nervous system disorders are included in the current safety information. However, the possibility of persistent duration of these events is not included in the safety information for all fluoroquinolone products.
  • There was little information in the scientific and medical literature on persistent and disabling nature of side effects reported with fluoroquinolone use, but the information available supports a link between the use of fluoroquinolones and persistent disability, especially for side effects such as tendinopathy and peripheral neuropathy.

Conclusions and Actions

  • Health Canada's review concluded that some of the known side effects, specifically tendonitis/tendinopathy, peripheral neuropathy and central nervous system disorders, already linked to the use of fluoroquinolones, may be persistent and/or disabling. Given the high use of fluoroquinolones in Canada and the information reviewed, these side effects are considered rare.
  • Health Canada recommended that the safety information for all fluoroquinolone products be updated to include information about this rare but serious risk. Health Canada is working with manufacturers to update the safety information of all systemic (taken by mouth or by injection) fluoroquinolone products marketed in Canada. In addition, an Information Update and a Health Care Professional Letter will be published and distributed to further inform Canadians and healthcare professionals about this risk.
  • Health Canada is working with the Drug Safety and Effectiveness Network (DSEN) and the Canadian Agency for Drugs and Technologies in Health (CADTH) to conduct additional studies to better understand the use of fluoroquinolones in Canada.
  • On October 6, 2016, Health Canada brought together a Scientific Advisory Panel on Anti-Infective Therapies to discuss the risks associated with the use of fluoroquinolones. The panel recommended that the safety information for fluoroquinolones be updated, and risk communications be published and distributed to further inform Canadians and healthcare professionals about the potential risk that some of the known side effects, specifically tendonitis/tendinopathy, peripheral neuropathy and central nervous system disorders may be persistent and/or disabling.
  • Health Canada will continue to monitor safety information involving fluoroquinolones, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of these drugs both in Canada and internationally.

References

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