Bromfenac and Pregnancy
Although bromfenac has not been studied in pregnant women, giving this drug to pregnant animals appeared to increase the risk for miscarriage and other problems. Due to the potential risks, a healthcare provider should only prescribe it during pregnancy if the benefits outweigh the risks.
Bromfenac ophthalmic solution (Bromday®, Prolensa™, Xibrom®) is a prescription nonsteroidal anti-inflammatory drug (NSAID) eye drop. This drug may not be safe for use in pregnant women, although the full risks are currently unknown.
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Bromfenac is classified as a pregnancy Category C medication.
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but do appear to cause fetal harm in animal studies. In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
This drug did not cause birth defects when given by mouth to pregnant rats and rabbits, even in very high doses. It did, however, increase the risk for miscarriages. It also reduced the growth of the offspring, and caused problems with labor and delivery in the pregnant rats. Bromfenac has not been studied in pregnant women.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
In general, NSAIDs are not recommended for use during late pregnancy because they have been reported to prevent labor and prolong pregnancy. Use of NSAIDs in late pregnancy has also been associated with premature closure of the ductus arteriosus. The ductus arteriosus is a blood vessel that is important to the fetal circulation. Although it closes shortly after birth (since it is no longer needed once a baby is born), serious problems can occur in the fetus if the ductus arteriosus closes too early.
As mentioned previously, bromfenac is a prescription eye drop medication. When used as directed in the eye, very little (if any) of the medicine is actually absorbed into the bloodstream. Therefore, it is unlikely that the drug would be associated with the same risks during pregnancy as oral NSAIDs (NSAIDs taken by mouth). For this reason, some resources state the medication is not likely to harm an unborn baby.
The manufacturer of bromfenac, however, recommends that it should not be used late in pregnancy because of the risk for premature closure of the ductus arteriosus. Because bromfenac has not been adequately studied in pregnant women, the possibility for this risk, though likely small, cannot be completely ruled out.