Bromfenac

There are no adequate data from the use of bromfenac in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Since the systemic exposure in non-pregnant women is negligible after treatment with bromfenac, the risk during pregnancy could be considered low.

However, because of the known effects of prostaglandin biosynthesis-inhibiting medicinal products on the foetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac during third trimester pregnancy should be avoided. The use of bromfenac is in general not recommended during pregnancy unless the benefit outweighs the potential risk.

It is unknown whether bromfenac or its metabolites are excreted in human milk. Animal studies have shown excretion of bromfenac in the milk of rats following very high oral doses. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to bromfenac is negligible. Bromfenac can be used during breast-feeding.

Fertility

No effects of bromfenac on the fertility were observed in animal studies. In addition the systemic exposure to bromfenac is negligible; for this reason no pregnancy testing or contraceptive measures are required.

Bromfenac has minor influence on the ability to drive and use machines. Transient blurring of vision may occur on instillation. If blurred vision occurs at instillation patients should be advised to refrain from driving or using machines until vision is clear.

Summary of the safety profile

Based on clinical data available, a total of 3.4% of patients experienced one or more adverse reactions. The most common or most important reactions in the pooled studies were abnormal sensation in eye (0.5%), corneal erosion (mild or moderate) (0.4%), eye pruritus (0.4%), eye pain (0.3%) and eye redness (0.3%). Corneal adverse reactions were only observed in the Japanese population. Adverse reactions rarely led to withdrawal, with a total of 8 (0.8%) patients who prematurely discontinued treatment in a study due to an adverse reaction. These comprised 3 (0.3%) patients with mild corneal erosion, 2 (0.2%) patients with eyelid oedema and 1 (0.1%) patient each with abnormal sensation in eye, corneal oedema, or eye pruritus.

List of adverse reactions

The following adverse reactions were 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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

The list below describes adverse reactions by system organ class and frequency.

Eye disorders

Uncommon: Visual acuity reduced, Haemorrhagic retinopathy, Corneal epithelium defect**, Corneal erosion (mild or moderate), Corneal epithelium disorder, Corneal oedema, Retinal exudates, Eye pain, Eyelid bleeding, Vision blurred, Photophobia, Eyelid oedema, Eye discharge, Eye pruritus, Eye irritation, Eye redness, Conjunctival hyperaemia, Abnormal sensation in eye, Ocular discomfort

Rare: Corneal perforation*, Corneal ulcer*, Corneal erosion, serious*, Scleromalacia*, Corneal infiltrates*, Corneal disorder*, Corneal scar*

Respiratory, thoracic and mediastinal disorders

Uncommon: Epistaxis, Cough, Nasal sinus drainage

Rare: Asthma*

General disorders and administrative site conditions

Uncommon: Face swelling

* Serious reports from post-marketing experience of more than 20 million patients
** Observed with four times daily dose

Patients with evidence of corneal epithelial breakdown should be instructed to immediately discontinue use of bromfenac and should be monitored closely for corneal health.