Summary Safety Review - Systemic and Inhaled Fluoroquinolone Antibiotics - Assessing the Potential Risk of Heart Valve Regurgitation
Review decision
A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Issued: 2021-08-27
Product
Fluoroquinolone antibiotics (ciprofloxacin-, levofloxacin-, moxifloxacin- and norfloxacin-containing products) administered by injection or by mouth (systemic) and by breathing in (inhaled).
Potential Safety Issue
Leaking heart valves (heart valve regurgitation).
Overview
Use in Canada
- Fluoroquinolones are a group of prescription antibiotic drugs authorized for sale in Canada to treat a wide range of bacterial infections, including urinary and respiratory tract infections. They can be administered by mouth (oral), by injection, by inhalation, or applied to the eyes and ears.
- Fluoroquinolones have been marketed in Canada since 1986 under different brand names and generics of ciprofloxacin, moxifloxacin, levofloxacin, and norfloxacin.
- About 2 million systemic and inhaled fluoroquinolone prescriptions are filled in Canadian retail pharmacies every year.
Safety Review Findings
- Health Canada reviewed the available information from searches of the Canada Vigilance databasea, international databases, and published literature.
- At the time of the review, Health Canada had not received any Canadian reports of heart valve regurgitation related to fluoroquinolone use.
- Health Canada reviewed 5 international case reports of heart valve regurgitation in patients receiving a fluoroquinolone that were retrieved from the Canada Vigilance database. Of the 5 case reports, 2 cases were found to be possibly linked with the use of a fluoroquinolone, 2 cases were unlikely to be linked, and one case did not have enough information to be assessed further.
- Health Canada's review of 2 articles in the scientific literature did not support a link between heart valve regurgitation and the use of fluoroquinolones. The first study1 reported an increased risk of heart valve regurgitation with fluoroquinolone use; however, limitations in the study design make the findings difficult to interpret. The second study2 did not have enough information to be assessed further.
Conclusions and actions
- Health Canada's review of the available information did not establish a link between the use of systemic or inhaled fluoroquinolones and the risk of heart valve regurgitation.
- Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of fluoroquinolones, and other health products, to the Canada Vigilance Program.
- 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 should new health risks be identified.
Additional information
The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information and what is known about the use of these drugs both in Canada and internationally.
For additional information, contact the Marketed Health Products Directorate.
References
- Etminan M, Sodhi M, Ganjizadeh-Zavareh S, Carleton B, Kezouh A, Brophy JM. Oral Fluoroquinolones and Risk of Mitral and Aortic Regurgitation. J Am Coll Cardiol. 2019;74(11):1444-1450. doi:10.1016/j.jacc.2019.07.035.
- Finkle W.D., Ridgeway G., Greenland S., Irwin D.E., Juneau P., Palmer L. Risk of aortic valve and neuropsychiatric disorders following an initial prescription for levofloxacin or ciprofloxacin in the elderly. Pharmacoepidemiol.Drug Saf. 2017;26:391-392. [abstract only]
Footnotes
- Canadian reports can be accessed through the Canada Vigilance Online Database.