Bromday and Pregnancy
Based on the results of animal studies, Bromday (bromfenac) is considered a pregnancy Category C medicine. This means that this drug may not be safe for women to use during pregnancy. When given to pregnant animals, the medication increased the risk for miscarriages, decreased the growth of the offspring, and caused problems with labor and delivery.
Bromday® (bromfenac ophthalmic solution) is a prescription eye drop approved to reduce swelling and pain following cataract surgery. It belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). At this time, the full risks of using this drug during pregnancy are 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. Bromday is classified as a pregnancy Category C medicine.
Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Bromday did not cause birth defects when given to pregnant rats or rabbits by mouth, even in very high doses. However, the highest doses studied caused miscarriages in the rats and rabbits. The drug also caused problems with labor and delivery and decreased the growth of the offspring when given to pregnant rats. Bromday 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 the unborn child.
It is generally recommended that NSAID medications, such as Bromday, be avoided during the third trimester of pregnancy (the last three months). This is because NSAIDs can cause complications during labor and delivery and may have negative effects on the heart of the fetus. In particular, when used during late pregnancy, NSAIDs may cause the ductus arteriosus to close too early.
The ductus arteriosus is a blood vessel that is important to the fetal blood circulation. It connects two arteries, and allows blood to bypass the fetal lungs (which aren't used when a baby is in the womb because the baby gets oxygen from the mother). Normally, the ductus arteriosus closes shortly after birth. It can be life-threatening for an unborn baby if the ductus arteriosus closes before birth.
It is important to keep in mind, however, that Bromday is a prescription eye drop, and very little (if any) of the medicine is absorbed into the bloodstream after normal use. Therefore, the drug is not likely to be associated with the same risks as NSAIDs taken by mouth.
However, until more information is available, the possibility that Bromday may be harmful if used during pregnancy cannot be ruled out. Because of the potential risk for problems, the manufacturer of the medication recommends that it should not be used during late pregnancy.