Bromfenac (ophthalmic) Pregnancy Warnings
Not recommended during third trimester of pregnancy.
Prior to third trimester: Use only if potential benefit justifies the potential risk to the fetus.
US FDA pregnancy category: C (0.07% and 0.09% ophthalmic solutions); not assigned (0.075% ophthalmic solution)
Risk summary (0.075% ophthalmic solution): No data available on use of this drug in pregnant women to inform a drug-related risk.
Comment:
-Because premature closure of the ductus arteriosus in the fetus has occurred with third trimester use of oral and injectable NSAIDs, use of this drug during the third trimester of pregnancy should be avoided.
Animal studies have revealed evidence of embryo lethality and maternal toxicity at doses 90 and 150 times the predicted human systemic exposure. Delayed parturition was also observed in rats at doses 30 times the predicted human systemic exposure. There are no controlled data in human pregnancy.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
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