Eye disorders reported with the use of mefloquine (Lariam(®)) chemoprophylaxis--A drug safety database analysis.

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.