Ocular safety of hydroxychloroquine sulfate (Plaquenil).

Analysis of all published cases and Food and Drug Administration (FDA) reports of retinopathy attributed to hydroxychloroquine sulfate (Plaquenil) does not reveal any evidence of permanent visual field scotoma occurring when the daily dose is related to body weight and does not exceed 6.5 mg/kg for maintenance therapy. Risk factors of unknown degree may appear at this dosage level only when the duration of treatment exceeds 10 years or when chronic renal insufficiency is present. In the absence of risk factors, annual ophthalmologic examinations and central field testing are recommended because non-drug-related macular diseases commonly occur in the older age group. When risk factors are present, more frequent examinations are indicated. A modified Amsler grid screening test for the central 10 degrees of visual field is described and the participation of the treating physician in the testing program is encouraged to provide maximal medicolegal protection.