Received 16 April 2009; received in revised form 14 May 2009; accepted 12 June 2009. published online 30 July 2009.
Purpose
To report a possible association between fluoroquinolones and diplopia.
Design
Database study.
Participants
A total of 171 subjects were studied.
Methods
Spontaneous reports from the National Registry of Drug-Induced Ocular Side Effects, World Health Organization, and Food and Drug Administration were collected on fluoroquinolones and diplopia.
Main Outcome Measures
Data garnered from the spontaneous reports include the type of fluoroquinolone, age, gender, adverse drug reaction (ADR), dosage, duration of therapy until onset of ADR, concomitant drugs, other systemic disease, and dechallenge and rechallenge data.
Results
A total of 171 case reports of diplopia associated with fluoroquinolones were reported, including 76 men, 91 women, and 4 case reports in which the gender was not specified. The median age was 51.6 years. Dosage varied between the different fluoroquinolone drugs, with the median dosage within the range recommended in the package insert for each different fluoroquinolone. Median time from beginning of therapy to appearance of the ADR was 9.6 days (range 1 day to 5 months). Seventeen subjects also had concomitant tendinitis, 49 patients were 60 years or older, 1 patient had renal cysts, and 4 patients were taking systemic anti-inflammatory steroids. There were 53 positive dechallenge and 5 positive rechallenge case reports.
Conclusions
According to World Health Organization criteria, the relationship between fluoroquinolone therapy and diplopia is “possible.” This causality assessment is based on the time relationship of drug administration and ADR development, the multiple positive dechallenge and rechallenge reports, and the plausible mechanism by which diplopia could occur: possible tendinitis of the extraocular muscles.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found after the references.
Available online: July 30, 2009.
Department of Ophthalmology (Casey Eye Institute), Oregon Health & Science University, Portland Oregon
Correspondence: Frederick W. Fraunfelder, MD, Casey Eye Institute Cornea Service, 3375 SW Terwilliger Blvd., Portland, OR 97239-4197
Manuscript no. 2009-529.
An abstract was submitted for presentation to the American Academy of Ophthalmology meeting, October 2009, San Francisco, California.
Financial Disclosure(s): The author(s) have made the following disclosure(s):
Dr. F.W. Fraunfelder serves as a consultant to Brymill and F.T. Fraunfelder is a consultant to Pfizer. The authors have no proprietary interest in the materials discussed.
Supported in part by an unrestricted grant to Casey Eye Institute from Research to Prevent Blindness, New York, NY.
ABSTRACT