title: Eye disorders reported with the use of mefloquine (Lariam(®)) chemoprophylaxis--A drug safety database analysis.
abstract: BACKGROUND
  Between 80 and 90 million travellers visit malaria endemic areas annually and many require malaria chemoprophylaxis. The characterization of the risk and nature of eye disorders occurring during the use of malaria chemoprophylaxis is relevant for travel medicine advisors.
  
  
  METHODS
  We did a database analysis on eye disorder adverse events reported for mefloquine (as Lariam®) using the F. Hoffmann-La Roche global drug safety database for the time frame February 1984 to January 18th, 2011. These adverse event reports were reviewed by a trained ophthalmologist. The analysis focused on 3 categories of eye disorders--Category 1: visual acuity; Category 2: anatomical parts of the eye and Category 3: neuro-ophthalmic events. To put our analysis in context, an extensive literature search on "mefloquine" and "eye disorders" was conducted.
  
  
  RESULTS
  A total of 591 cases with 695 events assigned to the "Eye disorder" SOC in individuals exposed to mefloquine chemoprophylaxis were reported. The highest proportion of events (n = 493, 70.9%) was in Category 1: visual acuity (mainly visual impairment and blurred vision), followed by Category 3: neuro-ophthalmic events (n = 124, 17.8%). The majority of visual adverse events were non-serious but 37.7% (n = 223) of cases were classified as serious. Nine events of maculopathy were reported and 48 cases with 53 events described symptoms of optic neuropathy.
  
  
  CONCLUSIONS
  Mefloquine, like other anti-malarials, may be associated with eye disorders. Prescribers of anti-malarials should inform travellers regarding the risk of potential ocular side effects. Users of chemoprophylaxis who experience visual disorders should be referred to an ophthalmologist.
authors.affiliation: Safety Risk Management, F. Hoffmann-La Roche, Basel, Switzerland. Electronic address: miriam.adamcova@roche.com.
authors.forename: Miriam
authors.initials: M
authors.lastname: Adamcova
authors.affiliation: Safety Risk Management, F. Hoffmann-La Roche, Basel, Switzerland.
authors.forename: Martin T
authors.initials: MT
authors.lastname: Schaerer
authors.affiliation: Safety Risk Management, F. Hoffmann-La Roche, Basel, Switzerland.
authors.forename: Isabella
authors.initials: I
authors.lastname: Bercaru
authors.affiliation: Safety Risk Management, F. Hoffmann-La Roche, Basel, Switzerland.
authors.forename: Iain
authors.initials: I
authors.lastname: Cockburn
authors.affiliation: Safety Risk Management, F. Hoffmann-La Roche, Basel, Switzerland.
authors.forename: Hans-Georg
authors.initials: HG
authors.lastname: Rhein
authors.affiliation: University of Zürich Centre for Travel Medicine, Hirschengraben 84, CH-8001, Zürich, Switzerland.
authors.forename: Patricia
authors.initials: P
authors.lastname: Schlagenhauf
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000962:Antimalarials / Q000009:adverse effects* / Q000627:therapeutic use; D018890:Chemoprevention / Q000009:adverse effects; D005128:Eye Diseases / Q000453:epidemiology; D005260:Female; D006801:Humans; D008288:Malaria / Q000188:drug therapy / Q000517:prevention & control; D008297:Male; D015767:Mefloquine / Q000009:adverse effects* / Q000627:therapeutic use; D008875:Middle Aged; D012189:Retrospective Studies; D055815:Young Adult
chemical_list: D000962:Antimalarials; D015767:Mefloquine
keywords: Eye disorder; Malaria chemoprophylaxis; Mefloquine