Nevanac Adverse Reactions

Summary of the safety profile: In clinical studies involving 2314 patients receiving NEVANAC 1 mg/ml the most common adverse reactions were punctate keratitis, foreign body sensation and eyelid margin crusting which occurred in between 0.4% and 0.2% of patients.
Tabulated list of adverse reactions: The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions were obtained from clinical trials and post-marketing reports. (See table.)

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Diabetic patients: In the two clinical studies involving 209 patients, diabetic patients were exposed to NEVANAC treatment for 60 days or greater for the prevention of macular oedema post cataract surgery. The most frequently reported adverse reaction was punctate keratitis which occurred in 3% of patients, resulting in a frequency category of common. The other reported adverse reactions were corneal epithelium defect and allergic dermatitis which occurred in 1% and 0.5% of patients, respectively both adverse reactions with a frequency category of uncommon.
Description of selected adverse reactions: Clinical trial experience for the long-term use of NEVANAC for the prevention of macular oedema post cataract surgery in diabetic patients is limited. Ocular adverse reactions in diabetic patients may occur at a higher frequency than observed in the general population (see Precautions).
Patients with evidence of corneal epithelial breakdown including corneal perforation should immediately discontinue use of NEVANAC and should be monitored closely for corneal health (see Precautions).
From post-marketing experience with NEVANAC, cases reporting corneal epithelium defect/disorder have been identified. Severity of these cases vary from non serious effects on the epithelial integrity of the corneal epithelium to more serious events where surgical interventions and/or medical therapy are required to regain clear vision.
Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (eg, dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse reactions which may become sight threatening. When nepafenac is prescribed to a diabetic patient post cataract surgery to prevent macular oedema, the existence of any additional risk factor should lead to reassessment of the foreseen benefit/risk and to intensified patient monitoring.
Paediatric population: The safety and efficacy of NEVANAC in children and adolescents have not been established.