Ophthalmic
PREGNANCY RECOMMENDATION: No Human Data—Probably Compatible
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
No reports describing the use of bromfenac in human pregnancy have been located. The animal reproduction data suggest low risk. Although the lack of human pregnancy experience does not allow a more complete assessment, the very small amounts, if any, of the drug in the systemic circulation suggest that it represents no risk to the embryo or fetus.
FETAL RISK SUMMARY
Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that is used topically as a 0.09% solution on the eye. It is indicated for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract extraction. The maximum recommended dose is one drop (0.09 mg) in each eye 2 times daily. It is not known if the drug is absorbed into the systemic circulation, but based on the dose, the amount in the systemic circulation is estimated to be below the limit of quantification (50 ng/mL) (1).
Reproduction studies have been conducted in rats and rabbits. In pregnant rats and rabbits, oral doses up to 540 and 4500 times, respectively, the recommended human ophthalmic dose revealed no evidence of teratogenicity. However, the highest dose in rats was associated with embryo, fetal, and neonatal death, and reduced postnatal growth. The highest dose in rabbits caused increased postimplantation loss (1).
It is not known if bromfenac crosses the human placenta. The molecular weight (about 254 for the nonhydrated free acid) is low enough, but only very small amounts, if any, are present in the systemic circulation. Thus, clinically significant exposure of the embryo or fetus is unlikely.
BREASTFEEDING SUMMARY
No reports describing the use of bromfenac during human lactation have been located. The molecular weight (about 254 for the nonhydrated free acid) is low enough for excretion into breast milk, but only very small amounts, if any, are present in the systemic circulation. Moreover, other NSAIDs are compatible with breastfeeding, even when given orally (e.g., see Ibuprofen). Therefore, the use bromfenac should also be compatible.
Reference
1.Product information. Xibrom. ISTA Pharmaceuticals, 2006.