Bromfenac sodium

General information

Bromfenac sodium (2-amino-3-(4-bromo-benzoyl)-benzeneacetic acid sodium salt sesquihydrate) has a safety profile apparently similar to that of other NSAIDs [ ]. It was approved by the FDA in 1997 for short-term management of acute pain, but was withdrawn by the manufacturers in 1998.

Bromfenac sodium ophthalmic solution 0.1%, a non-steroidal anti-inflammatory drug (NSAID) for ophthalmic use, has been reviewed [ ]. It is the most potent ophthalmic NSAID in inhibiting COX-2. Its penetration into ocular tissue is rapid and extensive. Peak concentrations in rabbit eyes occurred after 2 hours in aqueous humor and were present after 24 hours in every ocular tissue, including the retina. In humans the peak concentration occurred after 150–180 minutes. The effective concentration remained in the eye for 12 hours. Bromfenac reduced ocular inflammation after cataract surgery.

Ocular adverse events in phase 3 clinical trials were not more common in the treatment arms compared with patients who received the vehicle. Of 3425 patients 89% received bromfenac twice a day. Treatment periods of more than 28 days accounted for 32%. There were 56 patients (1.64%) with a total of 66 adverse events. The most frequently reported adverse events were corneal erosions (14 cases, 0.41%), blepharitis (six cases, 0.18%), superficial punctate keratitis, irritation, local pain, and pruritus (five each, 0.15%). There were three serious ocular adverse events: endophthalmitis, ocular hypertension, and branch retinal vein occlusion; these were predictable from concurrent diseases. Data were also collected from spontaneously reported adverse events in 7.8 million patients who had used bromfenac. 0.1%; there were 16 (0.0002%) adverse events: corneal ulcers (n = 4), corneal erosions (n = 3), corneal perforations (n = 3), corneal infiltrates (n = 3), corneal thinning (n = 2), and a defect of the corneal epithelium (n = 1). Systemic absorption seems to be negligible and no systemic adverse events have been reported. After 14 days of twice-daily dosing, liver function tests were normal in over 90% of the subjects and there was no evidence of hepatotoxicity. In 39 subjects with documented disorders of hepatic function before starting bromfenac, none had worsening of hepatic function or serious adverse events.